Determination of the Biological Activity of Serum From Patients (nutricell3)
Primary Purpose
Women, Rheumatoid Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
daily supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Women focused on measuring rheumatoid arthritis, probiotics
Eligibility Criteria
Inclusion Criteria:
Women
- 30-75 years
- Non-menopausal or menopausal for more than 2 years because the tissue osteoarticular is under the influence of steroid hormones. Peri-menopause is accompanied by strong hormonal variations.
- With rheumatoid arthritis (DAS28 threshold specified below)
- Clinical arthritis score ≥ 2.6 (DAS28). Pathology needs to be characterized even if the score remains low
- Person with good venous condition
Exclusion Criteria:
Vaccination in the last two months
- Alcohol abuse with regard to WHO standards
Smoking (>5 cigarettes/day)
-> 5 hours of intense sport per week
- Food allergy and others
- Antibiotic treatment in the month preceding inclusion
- Persons under guardianship, curators, deprived of liberties, safeguard of justice
- Refusal to sign the information and consent form
Sites / Locations
- Centre Hospitalier Emile RouxRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Traitement 1
Traitement 2
Traitement 3
Arm Description
Lactobacillus salivarius
Lactobacillus Rhamnosus GG
Bifidobacterium lactis
Outcomes
Primary Outcome Measures
Change of biological activity of serum between day 0 to day 28
Ex vivo quantification of the formation of osteoclast multi-nucleated cells following culture in the presence of metabolites from the serum of patients between day 0 and day 28
Secondary Outcome Measures
Change of Disease Activity Score (DAS28) day 0 to day 28
The Disease Activity Score (DAS) is a combined index to measure the disease activity in patients with rheumatoid arthritis (RA).
Evaluation of a patient's response to treatment can be made much easier and more objective using the DAS28. (Twenty-eight tender and swollen joint scores include the same joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees.) Simply assess the number of swollen and tender joints and measure the ESR. The DAS will provide you with a number between 0 and 10, indicating the activity rate of the rheumatoid arthritis is at that particular moment.
Full Information
NCT ID
NCT04696718
First Posted
December 7, 2020
Last Updated
August 10, 2022
Sponsor
Adeline BLOT
Collaborators
Centre Hospitalier Emile Roux, Centre de Recherche en Nutrition Humaine d'Auvergne
1. Study Identification
Unique Protocol Identification Number
NCT04696718
Brief Title
Determination of the Biological Activity of Serum From Patients
Acronym
nutricell3
Official Title
Determination of the Biological Activity of Serum From Patients With Rheumatoid Arthritis After Consumption of Three Different Probiotics Strains (Lactobacillus Salivarius, Rhamnosus, Bifidobacterium Lactis)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
December 22, 2022 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adeline BLOT
Collaborators
Centre Hospitalier Emile Roux, Centre de Recherche en Nutrition Humaine d'Auvergne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts).
The secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.
Detailed Description
The written consent of the subjects will be obtained after full information of the aims, nature and possible risks of the study.
Before inclusion, subjects will undergo a medical check-up including an interview on personal and family history and drug treatments taken as well as a standard medical examination including weight, height and blood pressure measurement. . Their compliance with the inclusion / exclusion criteria will be verified during this review. An interview with personnel involved in the research (a dietician / study Research clinic assistant, etc.) will also be carried out as well as a biological selection assessment.
As part of this study, the subjects will come a total of 7 times to the Emile ROUX hospital in Le Puy en Velay.
The probiotic treatment will begin between 1 and 3 weeks after the inclusion visit. The volunteers / patients recruited will have a volume of blood sampled and a stool collected before the start of the probiotic treatment (T = 0) and at the end of the treatment (T = 4 weeks). The study consists of three periods of probiotic treatment of 4 weeks each interspersed with a wash-out period of 3 weeks in accordance with the recovery period necessary between two blood samples.
The sera thus obtained will then be analyzed to determine their biological activity with regard to the induction of changes in the behavior of bone cell models: osteoformin cells (osteoblasts) and osteo-resorbent cells (osteoclasts).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women, Rheumatoid Arthritis
Keywords
rheumatoid arthritis, probiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment patient may receive 3 products in 3 interventions sequentially during the protocol
Masking
Participant
Masking Description
single blind
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traitement 1
Arm Type
Experimental
Arm Description
Lactobacillus salivarius
Arm Title
Traitement 2
Arm Type
Experimental
Arm Description
Lactobacillus Rhamnosus GG
Arm Title
Traitement 3
Arm Type
Experimental
Arm Description
Bifidobacterium lactis
Intervention Type
Dietary Supplement
Intervention Name(s)
daily supplementation
Intervention Description
the patients will consume 1 pill of probiotic each day for 28 days per treatments each treatment is separated by a wash out period of 21 days
Primary Outcome Measure Information:
Title
Change of biological activity of serum between day 0 to day 28
Description
Ex vivo quantification of the formation of osteoclast multi-nucleated cells following culture in the presence of metabolites from the serum of patients between day 0 and day 28
Time Frame
Day 0 and Day 28
Secondary Outcome Measure Information:
Title
Change of Disease Activity Score (DAS28) day 0 to day 28
Description
The Disease Activity Score (DAS) is a combined index to measure the disease activity in patients with rheumatoid arthritis (RA).
Evaluation of a patient's response to treatment can be made much easier and more objective using the DAS28. (Twenty-eight tender and swollen joint scores include the same joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees.) Simply assess the number of swollen and tender joints and measure the ESR. The DAS will provide you with a number between 0 and 10, indicating the activity rate of the rheumatoid arthritis is at that particular moment.
Time Frame
Day 0 and Day 28
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
higher prevalency of RA in women
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women
30-75 years
Non-menopausal or menopausal for more than 2 years because the tissue osteoarticular is under the influence of steroid hormones. Peri-menopause is accompanied by strong hormonal variations.
With rheumatoid arthritis (DAS28 threshold specified below)
Clinical arthritis score ≥ 2.6 (DAS28). Pathology needs to be characterized even if the score remains low
Person with good venous condition
Exclusion Criteria:
Vaccination in the last two months
Alcohol abuse with regard to WHO standards
Smoking (>5 cigarettes/day)
-> 5 hours of intense sport per week
Food allergy and others
Antibiotic treatment in the month preceding inclusion
Persons under guardianship, curators, deprived of liberties, safeguard of justice
Refusal to sign the information and consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yohann wittrant, PhD
Phone
+33682297271
Email
yohann.wittrant@inrae.fr
First Name & Middle Initial & Last Name or Official Title & Degree
emilie gadea, PhD
Email
responsable.rechercheclinique@ch-lepuy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
benjamin castagne, MD
Organizational Affiliation
Centre Hospitalier Emile Roux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Emile Roux
City
Le Puy-en-Velay
ZIP/Postal Code
43000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emile gadea, PhD
Email
responsable.rechercheclinique@ch-lepuy.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Determination of the Biological Activity of Serum From Patients
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