Back to resultsEvolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment and Response to it (MESAJ)
Primary Purpose
Spondylarthropathies
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stool collection at the patient's home.
Blood test
Sponsored by
About this trial
This is an interventional treatment trial for Spondylarthropathies focused on measuring Microbiota
Eligibility Criteria
Inclusion Criteria:
- Patients aged over 8 and under 16 years old.
- Patients diagnosed with arthritis with juvenile enthesitis according to the International League of Associations for Rheumatology (ILAR) criteria.
- Patients who haven't been treated by Methotrexate or biotherapy for at least 3 months.
- Patients who haven't been treated by cortisone for over a month.
- Patients whose parents have given written informed consent.
- Patients for whom the consent form has been signed by their legal guardian.
- Patients covered by the Social Security System or benefitting from private health insurance.
Exclusion Criteria:
- Patients enrolled in another category 1 study or who have already taken part in a category 1 study within 3 months prior to inclusion.
- Patients who are within an exclusion period determined by another study.
Sites / Locations
- Nîmes University HospitalRecruiting
- Montpellier University Hospital, Arnaud de Villeneuve HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Profile AB
Profile AM
Profile AMB
Profile A
Profile M
Profile B
Arm Description
Patients on non-steroidal anti-inflammatory drugs followed by biotherapy.
Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate.
Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy if there is no improvement with methotrexate.
Patients on non-steroidal anti-inflammatory drugs.
methotrexate alone
biotherapy alone
Outcomes
Primary Outcome Measures
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
- the diversity index according to the number of species and the number of functional groups.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
the physician's global assessment of disease activity;
the parent/guardian's or patient's global assessment of overall wellbeing;
number of joints with active arthritis; and
C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of flare-ups.
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) will be noted.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species detected in the intestinal microbiota.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM).Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM)
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
the physician's global assessment of disease activity;
the parent/guardian's or patient's global assessment of overall wellbeing;
number of joints with active arthritis; and
C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM). Number of flare-ups.
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM) will be noted.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
the physician's global assessment of disease activity;
the parent/guardian's or patient's global assessment of overall wellbeing;
number of joints with active arthritis; and
C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of flare-ups.
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) will be noted.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
the physician's global assessment of disease activity;
the parent/guardian's or patient's global assessment of overall wellbeing;
number of joints with active arthritis; and
C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of flare-ups.
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB) will be noted.
Secondary Outcome Measures
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
A: Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis.
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
C:Constitution of a biobank of samples from Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
All blood and stool samples used for the study will be deposited in the biobank for reference.
C: Constitution of a biobank for Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate).
All blood and stool samples used for the study will be deposited in the biobank for reference.
C: Constitution of a biobank for Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
All blood and stool samples used for the study will be deposited in the biobank for reference.
C: Constitution of a biobank for AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
All blood and stool samples used for the study will be deposited in the biobank for reference.
Age of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Recorded in years
Weight of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Recorded in kilos
Height of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Recorded in cm.
Sex of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Male/Female
Previous treatment in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
NSAIDs : dosage and dates
Corticoids : dosage and dates
Antibiotics : dosage and dates
DMARDs : dosage and dates
Dietary habits in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
The investigators will record details of patients' dietary habits and, more particularly, note all foods which are excluded.
Food allergies in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
The investigators will record details of patients' food allergies.
Lifestyle of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
The investigators will record details of the patient's lifestyle:
Brothers and sisters (number and date of birth of each one)
Communities (date of entry)
Contact with animals
Age of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Recorded in years
Weight of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Recorded in kilos
Height of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Recorded in cm.
Sex of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Male/Female
Previous treatment in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
NSAIDs : dosage and dates
Corticoids : dosage and dates
Antibiotics : dosage and dates
DMARDs : dosage and dates
Dietary habits in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Food allergies in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
The investigators will record details of all patients' food allergies.
Lifestyle in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
The investigators will record details of the patient's lifestyle:
Brothers and sisters (number and date of birth of each one)
Communities (date of entry)
Contact with animals
Age of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Recorded in years
Weight of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Recorded in kilos
Height of Profile AB patients (treated with non-steroidal anti-inflammatory drugs for then biotherapy)
Recorded in cm.
Sex of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Male/Female
Previous treatment in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
NSAIDs : dosage and dates
Corticoids : dosage and dates
Antibiotics : dosage and dates
DMARDs : dosage and dates
Dietary habits in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Food allergies in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
The investigators will record details of all patients' food allergies.
Lifestyle in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
The investigators will record details of the patient's lifestyle:
Brothers and sisters (number and date of birth of each one)
Communities (date of entry)
Contact with animals
Age of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate biotherapy)
Recorded in years
Weight of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Recorded in kilos
Height of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Recorded in cm.
Sex of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Male/Female
Previous treatment in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
NSAIDs : dosage and dates
Corticoids : dosage and dates
Antibiotics : dosage and dates
DMARDs : dosage and dates
Dietary habits in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Food allergies in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
The investigators will record details of all patients' food allergies.
Lifestyle in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
The investigators will record details of the patient's lifestyle:
Brothers and sisters (number and date of birth of each one)
Communities (date of entry)
Contact with animals
Full Information
NCT ID
NCT04540432
First Posted
August 27, 2020
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
University Hospital, Montpellier, Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04540432
Brief Title
Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment and Response to it
Acronym
MESAJ
Official Title
Descriptive Study on the Evolution of Intestinal Microbiota Profiles in Patients With Juvenile Spondylarthropathy According to the Typology of Treatment and Response to it: A Descriptive, Prospective Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
June 28, 2025 (Anticipated)
Study Completion Date
June 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
University Hospital, Montpellier, Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Idiopathic juvenile arthritis includes 20% of patients with arthritis with enthesitis or juvenile spondyloarthropathy. This is treated with anti-inflammatory drugs and then followed by biotherapy with DMARDs (Drugs Modifying the Activity of Rheumatic Disease) if the former are insufficient. Methotrexate (MTX) may also be used before these biotherapies. Recently, in adults, a particular profile of intestinal microbiota has been shown to alter the availability of MTX making it in efficient. Knowing that pediatric patients with juvenile spondyloarthropathy have an imbalance of their intestinal flora (dysbiosis) the investigators wanted to explore whether DMARDs could have a similar impact on the microbiota of these young patients and alter the response to treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylarthropathies
Keywords
Microbiota
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be split into 4 groups according to their treatment profile:
Profile A = patients on non-steroidal anti-inflammatory drugs.
Profile AM = patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate until the end of the study.
Profile AB = patients on non-steroidal anti-inflammatory drugs, followed by biotherapy until the end of the study.
Profile AMB = patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy until the end of the study.
Profile M : methotrexate alone
Profile B : biothérapy alone
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Profile AB
Arm Type
Experimental
Arm Description
Patients on non-steroidal anti-inflammatory drugs followed by biotherapy.
Arm Title
Profile AM
Arm Type
Experimental
Arm Description
Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate.
Arm Title
Profile AMB
Arm Type
Experimental
Arm Description
Patients on non-steroidal anti-inflammatory drugs followed by treatment with methotrexate and then biotherapy if there is no improvement with methotrexate.
Arm Title
Profile A
Arm Type
Experimental
Arm Description
Patients on non-steroidal anti-inflammatory drugs.
Arm Title
Profile M
Arm Type
Experimental
Arm Description
methotrexate alone
Arm Title
Profile B
Arm Type
Experimental
Arm Description
biotherapy alone
Intervention Type
Other
Intervention Name(s)
Stool collection at the patient's home.
Intervention Description
Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test
Intervention Description
7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.
Primary Outcome Measure Information:
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
- the diversity index according to the number of species and the number of functional groups.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Distribution of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Diversity of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
After 1 month of treatment
Title
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Description
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
the physician's global assessment of disease activity;
the parent/guardian's or patient's global assessment of overall wellbeing;
number of joints with active arthritis; and
C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Time Frame
After 1 month of treatment
Title
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A). Number of flare-ups.
Description
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) will be noted.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species detected in the intestinal microbiota.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM).Number of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Number of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Time Frame
After 6 months of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Distribution of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.
Time Frame
After 6 months of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM). Diversity of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
After 6 months of treatment
Title
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM)
Description
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
the physician's global assessment of disease activity;
the parent/guardian's or patient's global assessment of overall wellbeing;
number of joints with active arthritis; and
C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Time Frame
After 6 months of treatment
Title
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM). Number of flare-ups.
Description
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs for 1 month followed by methotrexate for 5 months (Profile AM) will be noted.
Time Frame
After 6 months of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species in the microbiota will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Time Frame
After 6 months of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Distribution of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
After 6 months of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Diversity of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
After 6 months of treatment
Title
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Description
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
the physician's global assessment of disease activity;
the parent/guardian's or patient's global assessment of overall wellbeing;
number of joints with active arthritis; and
C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Time Frame
After 6 months of treatment
Title
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB). Number of flare-ups.
Description
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) will be noted.
Time Frame
After 6 months of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The number of species detected in the intestinal microbiota will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department.The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
24 hours after inclusion
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
After 1 month of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The number of species detected in the intestinal microbiota will be recorded.
Time Frame
After 6 months of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Distribution of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded.
Time Frame
After 6 months of treatment
Title
Evolution of the intestinal microbiota in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Diversity of species.
Description
Patients will provide 2 stool samples (one for analysis and one for the biobank) taken at the patient's home, preserved at -20°C and transported in a coolerbag to the hospital. One sample will be frozen to -80°C for the biobank and one sample will be kept at -20°C at the pediatric department. The diversity index according to the number of species and the number of functional groups will be recorded.
Time Frame
After 6 months of treatment
Title
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Description
The JADAS CRP clinical score will be used to rate the degree of activity of the disease. The Juvenile Arthritis Disease Activity Score (JADAS) is a recently developed composite tool for scoring disease activity in juvenile idiopathic arthritis. It is a composite disease activity score including four measures:
the physician's global assessment of disease activity;
the parent/guardian's or patient's global assessment of overall wellbeing;
number of joints with active arthritis; and
C-reactive protein (CRP) which has been determined as an alternative inflammatory marker to the Erythrocyte Sedimentation Rate ESR. JADAS-CRP was calculated similarly to the original JADAS as the simple sum of its four components, yielding a global score of 0-40, 0-57 and 0-101 depending on the joint count used for the JADAS10-CRP, JADAS27-CRP and JADAS71-CRP, respectively.
Time Frame
After 6 months of treatment
Title
Response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB). Number of flare-ups.
Description
The number of flare-ups in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB) will be noted.
Time Frame
After 6 months of treatment
Secondary Outcome Measure Information:
Title
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.
Description
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Time Frame
24 hours after inclusion
Title
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs alone (Profile A) and the clinical stage of evolution of Juvenile Spondylarthitis.
Description
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Time Frame
After 1 month of treatment
Title
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.
Description
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Time Frame
24 hours after inclusion
Title
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM) and the clinical stage of evolution of Juvenile Spondylarthitis.
Description
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Time Frame
After 6 months of treatment
Title
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis.
Description
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Time Frame
24 hours after inclusion
Title
A: Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB) and the clinical stage of evolution of Juvenile Spondylarthitis.
Description
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Time Frame
After 6 months of treatment
Title
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis.
Description
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Time Frame
24 hours after inclusion
Title
A:Correlation between intestinal microbiota of patients treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy (Profile AMB) and the clinical stage of evolution of Juvenile Spondylarthitis.
Description
The description of the intestinal microbiota profile according to INSERM laboratory Unit 1047 will be correlated with the clinical stage of the disease (on remission or acute flare) before and after treatment.
Time Frame
After 6 months of treatment
Title
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Description
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Time Frame
24 hours after inclusion
Title
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs alone (Profile A)
Description
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Time Frame
After 1 month of treatment
Title
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
Description
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Time Frame
24 hours after inclusion
Title
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate (Profile AM)
Description
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Time Frame
After 6 months of treatment
Title
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Description
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Time Frame
24 hours after inclusion
Title
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by biotherapy (Profile AB)
Description
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Time Frame
After 6 months of treatment
Title
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Description
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Time Frame
24 hours after inclusion
Title
B:Correlation between bacterial translocation and response to treatment in patients treated with non-steroidal anti-inflammatory drugs followed by methotrexate then biotherapy (Profile AMB)
Description
Pre- and post-therapeutic translocation and response to treatment (presence/absence: detection of DNA 16S in the blood, quantification by quantitative PCR and sequencing for identification).
Time Frame
After 6 months of treatment
Title
C:Constitution of a biobank of samples from Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
All blood and stool samples used for the study will be deposited in the biobank for reference.
Time Frame
After 6 months of treatment
Title
C: Constitution of a biobank for Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate).
Description
All blood and stool samples used for the study will be deposited in the biobank for reference.
Time Frame
After 6 months of treatment
Title
C: Constitution of a biobank for Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Description
All blood and stool samples used for the study will be deposited in the biobank for reference.
Time Frame
At the inclusion visit on Day 0
Title
C: Constitution of a biobank for AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Description
All blood and stool samples used for the study will be deposited in the biobank for reference.
Time Frame
At the inclusion visit on Day 0
Title
Age of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
Recorded in years
Time Frame
At the inclusion visit on Day 0
Title
Weight of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
Recorded in kilos
Time Frame
At the inclusion visit on Day 0
Title
Height of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
Recorded in cm.
Time Frame
At the inclusion visit on Day 0
Title
Sex of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
Male/Female
Time Frame
At the inclusion visit on Day 0
Title
Previous treatment in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
NSAIDs : dosage and dates
Corticoids : dosage and dates
Antibiotics : dosage and dates
DMARDs : dosage and dates
Time Frame
At the inclusion visit on Day 0
Title
Dietary habits in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
The investigators will record details of patients' dietary habits and, more particularly, note all foods which are excluded.
Time Frame
At the inclusion visit on Day 0
Title
Food allergies in Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
The investigators will record details of patients' food allergies.
Time Frame
At the inclusion visit on Day 0
Title
Lifestyle of Profile A patients (treated with non-steroidal anti-inflammatory drugs alone)
Description
The investigators will record details of the patient's lifestyle:
Brothers and sisters (number and date of birth of each one)
Communities (date of entry)
Contact with animals
Time Frame
At the inclusion visit on Day 0
Title
Age of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Description
Recorded in years
Time Frame
At the inclusion visit on Day 0
Title
Weight of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Description
Recorded in kilos
Time Frame
At the inclusion visit on Day 0
Title
Height of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Description
Recorded in cm.
Time Frame
At the inclusion visit on Day 0
Title
Sex of Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Description
Male/Female
Time Frame
At the inclusion visit on Day 0
Title
Previous treatment in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Description
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
NSAIDs : dosage and dates
Corticoids : dosage and dates
Antibiotics : dosage and dates
DMARDs : dosage and dates
Time Frame
At the inclusion visit on Day 0
Title
Dietary habits in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Description
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Time Frame
At the inclusion visit on Day 0
Title
Food allergies in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Description
The investigators will record details of all patients' food allergies.
Time Frame
At the inclusion visit on Day 0
Title
Lifestyle in Profile AM patients (treated with non-steroidal anti-inflammatory drugs then methotrexate)
Description
The investigators will record details of the patient's lifestyle:
Brothers and sisters (number and date of birth of each one)
Communities (date of entry)
Contact with animals
Time Frame
At the inclusion visit on Day 0
Title
Age of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Description
Recorded in years
Time Frame
At the inclusion visit on Day 0
Title
Weight of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Description
Recorded in kilos
Time Frame
At the inclusion visit on Day 0
Title
Height of Profile AB patients (treated with non-steroidal anti-inflammatory drugs for then biotherapy)
Description
Recorded in cm.
Time Frame
At the inclusion visit on Day 0
Title
Sex of Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Description
Male/Female
Time Frame
At the inclusion visit on Day 0
Title
Previous treatment in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Description
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
NSAIDs : dosage and dates
Corticoids : dosage and dates
Antibiotics : dosage and dates
DMARDs : dosage and dates
Time Frame
At the inclusion visit on Day 0
Title
Dietary habits in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Description
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Time Frame
At the inclusion visit on Day 0
Title
Food allergies in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Description
The investigators will record details of all patients' food allergies.
Time Frame
At the inclusion visit on Day 0
Title
Lifestyle in Profile AB patients (treated with non-steroidal anti-inflammatory drugs then biotherapy)
Description
The investigators will record details of the patient's lifestyle:
Brothers and sisters (number and date of birth of each one)
Communities (date of entry)
Contact with animals
Time Frame
At the inclusion visit on Day 0
Title
Age of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate biotherapy)
Description
Recorded in years
Time Frame
At the inclusion visit on Day 0
Title
Weight of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Description
Recorded in kilos
Time Frame
At the inclusion visit on Day 0
Title
Height of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Description
Recorded in cm.
Time Frame
At the inclusion visit on Day 0
Title
Sex of Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Description
Male/Female
Time Frame
At the inclusion visit on Day 0
Title
Previous treatment in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Description
The investigators will record details of all treatment followed prior to diagnosis of juvenile spondylarthritis:
NSAIDs : dosage and dates
Corticoids : dosage and dates
Antibiotics : dosage and dates
DMARDs : dosage and dates
Time Frame
At the inclusion visit on Day 0
Title
Dietary habits in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Description
The investigators will record details of all patients' dietary habits and, more particularly, note all foods which are excluded.
Time Frame
At the inclusion visit on Day 0
Title
Food allergies in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Description
The investigators will record details of all patients' food allergies.
Time Frame
At the inclusion visit on Day 0
Title
Lifestyle in Profile AMB patients (treated with non-steroidal anti-inflammatory drugs then methotrexate then biotherapy)
Description
The investigators will record details of the patient's lifestyle:
Brothers and sisters (number and date of birth of each one)
Communities (date of entry)
Contact with animals
Time Frame
At the inclusion visit on Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged over 8 and under 16 years old.
Patients diagnosed with arthritis with juvenile enthesitis according to the International League of Associations for Rheumatology (ILAR) criteria.
Patients who haven't been treated by Methotrexate or biotherapy for at least 3 months.
Patients who haven't been treated by cortisone for over a month.
Patients whose parents have given written informed consent.
Patients for whom the consent form has been signed by their legal guardian.
Patients covered by the Social Security System or benefitting from private health insurance.
Exclusion Criteria:
Patients enrolled in another category 1 study or who have already taken part in a category 1 study within 3 months prior to inclusion.
Patients who are within an exclusion period determined by another study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tu-Anh TRAN, Professor
Phone
+33 4 66 32 86
Email
tu.anh.tran@chu-nimes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Philippe LAVIGNE, Professor
Phone
+334 66 68 32 02
Email
jean.philippe.lavigne@chu-nimes.fr
Facility Information:
Facility Name
Nîmes University Hospital
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa MEGZARI
Phone
+33 4 66 68 42 36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Tu-Anh TRAN, Prof.
First Name & Middle Initial & Last Name & Degree
Anne FILLERON, Dr.
First Name & Middle Initial & Last Name & Degree
Renaud CEZAR, Hospital engineer
First Name & Middle Initial & Last Name & Degree
Catherine DUNYACH-REMY, Dr.
First Name & Middle Initial & Last Name & Degree
Jean-Philippe LAVIGNE, Prof.
Facility Name
Montpellier University Hospital, Arnaud de Villeneuve Hospital
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric JEZIORSKI, Dr.
Phone
+33 4 67 33 22 86
Email
e-jeziorski@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Eric JEZIORSKI, Dr.
First Name & Middle Initial & Last Name & Degree
Aurelia CARBASSE, Dr.
12. IPD Sharing Statement
Learn more about this trial
Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment and Response to it
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