search
Back to results

Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17 (RESPOND-IL17)

Primary Purpose

Axial Spondyloarthritis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Daily dietary supplementation with Fibruline
Anti-IL-17 therapy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring dysbiosis, short-chain fatty acids, fiber, microbiota

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Patients with spondyloarthritis meeting the ASAS criteria Patient considered by the treating rheumatologist for anti-IL-17 biomedication Patients aged between 18 and 90 years of age Patients who are affiliated to a French social security system or beneficiaries of such a system Patients with no desire to become pregnant during the study period (Effective contraception for women of childbearing age during the study period (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device)) Exclusion Criteria: Lack of written informed consent after a time of reflection Patients participating in other therapeutic research or having participated in research for which the exclusion period has not ended Patient under court protection, guardianship or curatorship. Patient unable to give consent. Pregnant or breastfeeding woman Patients with digestive disorders for which a chronic inflammatory bowel disease has not been excluded Patients with fructose intolerance or glucose or galactose malabsorption Patients with known intolerance to inulin or maltodextrin

Sites / Locations

  • Nîmes University HospitalRecruiting
  • Montpellier University HospitalRecruiting
  • Tours Regional University Hospital (Bretonneau)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

Patients with aSp receiving fiber supplements in the form of Fibruline® Instant (Fagron laboratories)

Patients with aSp receiving fake fiber supplements (placebo) in the form of Maltodextrine (laboratoire Fagron).

Outcomes

Primary Outcome Measures

Clostridial changes in the Experimental group
Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Clostridial changes in Controls
Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Clostridial changes in the Experimental group
Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Clostridial changes in Controls
Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

Secondary Outcome Measures

Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASAS20 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASAS20 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASAS40 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASAS40 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Effect of fiber supplementation on clinical therapeutic response: GIQLI
Clinical response rates in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Effect of fiber supplmentation on clinical therapeutic response: GIQLI
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Effect at 12 weeks of placebo on clinical therapeutic response: ASA20
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASAS20 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Effect at 12 weeks of placebo on clinical therapeutic response: ASA20
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASAS20 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Effect at 12 weeks of placebo on clinical therapeutic response: ASA40
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASAS40 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Effect at 12 weeks of placebo on clinical therapeutic response: ASA40
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASAS40 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Effect of placebo on clinical therapeutic response: GIQLI
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Effect of placebo on clinical therapeutic response: GIQLI
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Tolerance of anti-IL17 intervention and treatment in the experimental group: Permeability
Changes in serum concentrations of intestinal permeability markers (zonulin, claudin-3, iFABP); and endotoxemia (LBP, CD14s) will be measured by ELISA in ng/ml
Tolerance of anti-IL17 intervention and treatment in controls: Permeability
Changes in serum concentrations of intestinal permeability markers (zonulin, claudin-3, iFABP); and endotoxemia (LBP, CD14s) will be measured by ELISA in ng/ml
Tolerance of anti-IL17 intervention and treatment in the experimental group
The distribution and diversity of different germs will be measured by 16S RNA sequencing. Quantitative
Tolerance of anti-IL17 intervention and treatment in controls
The distribution and diversity of different germs will be measured by 16S RNA sequencing. Quantitative
Presence of candida in patients in the experimental group
YES/NO
Presence of candida in patients in the control group
YES/NO
Tolerance of treatment in the experimental group
All adverse events related or not to anti-IL17 treatment and potentially associated with the consumption of high doses of fiber (bloating, flatulence, diarrhea, abdominal pain) will be recorded
Tolerance of treatment in the control group
All adverse events related or not to anti-IL17 treatment and potentially associated with the consumption of high doses of fiber (bloating, flatulence, diarrhea, abdominal pain) will be recorded
Complete blood count: Red blood cells in the experimental group
Red blood cells will be measured in millions/mm3
Complete blood count: Red blood cells in the control group
Red blood cells will be measured in millions/mm3
Complete blood count: Red blood cells in the experimental group
Red blood cells will be measured in millions/mm3
Complete blood count: Red blood cells in the control group
Red blood cells will be measured in millions/mm3
Complete blood count: White blood cells in the experimental group
White blood cells will be measured in millions/mm3
Complete blood count: White blood cells in the control group
White blood cells will be measured in millions/mm3
Complete blood count: White blood cells in the experimental group
White blood cells will be measured in millions/mm3
Complete blood count: White blood cells in the control group
White blood cells will be measured in millions/mm3
Complete blood count: Hemoglobin in the experimental group
Hemoglobin will be measured in g/L
Complete blood count: Hemoglobin in the control group
Hemoglobin will be measured in g/L
Complete blood count: Hemoglobin in the experimental group
Hemoglobin will be measured in g/L
Complete blood count: Hemoglobin in the control group
Hemoglobin will be measured in g/L
Complete blood count: Hematocrit in the experimental group
Hematocrit will be measured as a % of whole blood
Complete blood count: Hematocrit in the control group
Hematocrit will be measured as a % of whole blood
Complete blood count: Hematocrit in the experimental group
Hematocrit will be measured as a % of whole blood
Complete blood count: Hematocrit in the control group
Hematocrit will be measured as a % of whole blood
Complete blood count: Platelets in the experimental group
Platelets will be measured in K/µL
Complete blood count: Platelets in the control group
Platelets will be measured in K/µL
Complete blood count: Platelets in the experimental group
Platelets will be measured in K/µL
Complete blood count: Platelets in the control group
Platelets will be measured in K/µL
T-lymphocytes in the experimental group
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
T-lymphocytes in the control group
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
T-lymphocytes in the experimental group
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
T-lymphocytes in the control group
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Monocytes in the experimental group
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Monocytes in the control group
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Monocytes in the experimental group
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Monocytes in the control group
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Aspartate aminotransferase (ASAT) in the experimental group
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Aspartate aminotransferase (ASAT) in the experimental group
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Aspartate aminotransferase (ASAT) in the control group
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Aspartate aminotransferase (ASAT) in the control group
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Alanine aminotransferase (ALAT) in the experimental group
Alanine aminotransferase (ALAT) will be measured in international units per liter
Alanine aminotransferase (ALAT) in the experimental group
Alanine aminotransferase (ALAT) will be measured in international units per liter
Alanine aminotransferase (ALAT) in the control group
Alanine aminotransferase (ALAT) will be measured in international units per liter
Alanine aminotransferase (ALAT) in the control group
Alanine aminotransferase (ALAT) will be measured in international units per liter
Alkaline phosphatase in the experimental group
Alkaline phosphatase (ALP) will be measured in units per liter
Alkaline phosphatase in the experimental group
Alkaline phosphatase (ALP) will be measured in units per liter
Alkaline phosphatase in the control group
Alkaline phosphatase (ALP) will be measured in units per liter
Alkaline phosphatase in the control group
Alkaline phosphatase (ALP) will be measured in units per liter
Calcium in the experimental group
Calcium will be measured in mmol/L
Calcium in the experimental group
Calcium will be measured in mmol/L
Calcium in the control group
Calcium will be measured in mmol/L
Calcium in the control group
Calcium will be measured in mmol/L
Creatinine in the experimental group
Calcium will be measured in μmol/L
Creatinine in the experimental group
Calcium will be measured in μmol/L
Creatinine in the control group
Calcium will be measured in μmol/L
Creatinine in the control group
Calcium will be measured in μmol/L
Albumin in the experimental group
Albumin will be measured in g/liter
Albumin in the experimental group
Albumin will be measured in g/liter
Albumin in the control group
Albumin will be measured in g/liter
Albumin in the control group
Albumin will be measured in g/liter
Urea in the experimental group
Urea will be measured in mmol/L
Urea in the experimental group
Urea will be measured in mmol/L
Urea in the control group
Urea will be measured in mmol/L
Urea in the control group
Urea will be measured in mmol/L
Bilirubin in the experimental group
Bilirubin will be measured in µmol/L
Bilirubin in the experimental group
Bilirubin will be measured in µmol/L
Bilirubin in the control group
Bilirubin will be measured in µmol/L
Bilirubin in the control group
Bilirubin will be measured in µmol/L
C-Reactive Protein in the experimental group
C-Reactive Protein will be measured in mg/L
C-Reactive Protein in the experimental group
C-Reactive Protein will be measured in mg/L
C-Reactive Protein in the control group
C-Reactive Protein will be measured in mg/L
C-Reactive Protein in the control group
C-Reactive Protein will be measured in mg/L

Full Information

First Posted
March 31, 2023
Last Updated
October 3, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
search

1. Study Identification

Unique Protocol Identification Number
NCT05812157
Brief Title
Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17
Acronym
RESPOND-IL17
Official Title
Optimization of Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in patients with axial spondyloarthritis (AxSpA) and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments. The hypothesis is that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and improve AxSpA.
Detailed Description
Axial spondyloarthritis (AxSpA) is the second most common chronic inflammatory rheumatic disease, which develops preferentially in young subjects and results in a significant impairment of quality of life, particularly due to painful symptoms. The importance of the digestive system has long been recognized, since this disease is considered to be part of a larger group of diseases including Crohn's disease and ulcerative colitis because of their frequent association in the same patient, and because leaky gut disorders and alterations of the intestinal microbiota (dysbiosis) have been described in these patients. These abnormalities may stimulate the immune system and therefore be involved in inflammatory processes (especially Th17). The available treatments are based on non-steroidal anti-inflammatory drugs, and in the event of failure or intolerance, biomedicines targeting TNF can be used. Therapeutic monoclonal antibodies against IL-17 have recently enriched the therapeutic arsenal. Although most anti-TNF agents have a beneficial effect on the rheumatologic and digestive aspects of these diseases, anti-IL-17 agents are not expected to be effective in inflammatory bowel diseases. Indeed, a deleterious role of anti-IL-17 on the intestinal microbiota has even been demonstrated, which could result in a reduction of the systemic anti-inflammatory effect expected from these molecules, and consequently of the clinical benefit felt by the patient. In fact, anti-IL-17s lead to a significant decrease in Clostridiales, bacteria that participate in intestinal homeostasis. Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in just a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in AxSpA patients and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments. The hypothesis is therefore that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and thus improve AxSpA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
dysbiosis, short-chain fatty acids, fiber, microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, double-blind, prospective, randomized controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All treatments will be numbered. The treatment number will be assigned according to the randomization list. All participants (patient/evaluator/etc.) will be blinded to the treatment administered. Only the hospital pharmacy will know the assigned treatment and will guarantee the blinding.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients with aSp receiving fiber supplements in the form of Fibruline® Instant (Fagron laboratories)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients with aSp receiving fake fiber supplements (placebo) in the form of Maltodextrine (laboratoire Fagron).
Intervention Type
Dietary Supplement
Intervention Name(s)
Daily dietary supplementation with Fibruline
Intervention Description
Supplementation with 12 grams per day of Fibruline reconstituted with 60mL of water, once a day
Intervention Type
Drug
Intervention Name(s)
Anti-IL-17 therapy
Intervention Description
Patients in both groups will be on anti-IL-17 therapy
Primary Outcome Measure Information:
Title
Clostridial changes in the Experimental group
Description
Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Time Frame
Week 0
Title
Clostridial changes in Controls
Description
Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Time Frame
Week 0
Title
Clostridial changes in the Experimental group
Description
Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Time Frame
Week 12
Title
Clostridial changes in Controls
Description
Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI
Description
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Time Frame
Week 0
Title
Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Time Frame
Week 12
Title
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20
Description
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASAS20 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Time Frame
Week 0
Title
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASAS20 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Time Frame
Week 12
Title
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40
Description
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASAS40 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Time Frame
Week 0
Title
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASAS40 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Time Frame
Week 12
Title
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Time Frame
Week 0
Title
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Time Frame
Week 12
Title
Effect of fiber supplementation on clinical therapeutic response: GIQLI
Description
Clinical response rates in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Time Frame
Week 0
Title
Effect of fiber supplmentation on clinical therapeutic response: GIQLI
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage. Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Time Frame
Week 12
Title
Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI
Description
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Time Frame
Week 0
Title
Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Time Frame
Week 12
Title
Effect at 12 weeks of placebo on clinical therapeutic response: ASA20
Description
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASAS20 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Time Frame
Week 0
Title
Effect at 12 weeks of placebo on clinical therapeutic response: ASA20
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASAS20 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Time Frame
Week 12
Title
Effect at 12 weeks of placebo on clinical therapeutic response: ASA40
Description
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASAS40 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Time Frame
Week 0
Title
Effect at 12 weeks of placebo on clinical therapeutic response: ASA40
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASAS40 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Time Frame
Week 12
Title
Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Time Frame
Week 0
Title
Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Time Frame
Week 12
Title
Effect of placebo on clinical therapeutic response: GIQLI
Description
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Time Frame
Week 0
Title
Effect of placebo on clinical therapeutic response: GIQLI
Description
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Time Frame
Week 12
Title
Tolerance of anti-IL17 intervention and treatment in the experimental group: Permeability
Description
Changes in serum concentrations of intestinal permeability markers (zonulin, claudin-3, iFABP); and endotoxemia (LBP, CD14s) will be measured by ELISA in ng/ml
Time Frame
Month 0
Title
Tolerance of anti-IL17 intervention and treatment in controls: Permeability
Description
Changes in serum concentrations of intestinal permeability markers (zonulin, claudin-3, iFABP); and endotoxemia (LBP, CD14s) will be measured by ELISA in ng/ml
Time Frame
Month 3
Title
Tolerance of anti-IL17 intervention and treatment in the experimental group
Description
The distribution and diversity of different germs will be measured by 16S RNA sequencing. Quantitative
Time Frame
Month 3
Title
Tolerance of anti-IL17 intervention and treatment in controls
Description
The distribution and diversity of different germs will be measured by 16S RNA sequencing. Quantitative
Time Frame
Month 3
Title
Presence of candida in patients in the experimental group
Description
YES/NO
Time Frame
Month 3
Title
Presence of candida in patients in the control group
Description
YES/NO
Time Frame
Month 3
Title
Tolerance of treatment in the experimental group
Description
All adverse events related or not to anti-IL17 treatment and potentially associated with the consumption of high doses of fiber (bloating, flatulence, diarrhea, abdominal pain) will be recorded
Time Frame
Month 3
Title
Tolerance of treatment in the control group
Description
All adverse events related or not to anti-IL17 treatment and potentially associated with the consumption of high doses of fiber (bloating, flatulence, diarrhea, abdominal pain) will be recorded
Time Frame
Month 3
Title
Complete blood count: Red blood cells in the experimental group
Description
Red blood cells will be measured in millions/mm3
Time Frame
Month 0
Title
Complete blood count: Red blood cells in the control group
Description
Red blood cells will be measured in millions/mm3
Time Frame
Month 0
Title
Complete blood count: Red blood cells in the experimental group
Description
Red blood cells will be measured in millions/mm3
Time Frame
Month 3
Title
Complete blood count: Red blood cells in the control group
Description
Red blood cells will be measured in millions/mm3
Time Frame
Month 3
Title
Complete blood count: White blood cells in the experimental group
Description
White blood cells will be measured in millions/mm3
Time Frame
Month 0
Title
Complete blood count: White blood cells in the control group
Description
White blood cells will be measured in millions/mm3
Time Frame
Month 0
Title
Complete blood count: White blood cells in the experimental group
Description
White blood cells will be measured in millions/mm3
Time Frame
Month 3
Title
Complete blood count: White blood cells in the control group
Description
White blood cells will be measured in millions/mm3
Time Frame
Month 3
Title
Complete blood count: Hemoglobin in the experimental group
Description
Hemoglobin will be measured in g/L
Time Frame
Month 0
Title
Complete blood count: Hemoglobin in the control group
Description
Hemoglobin will be measured in g/L
Time Frame
Month 0
Title
Complete blood count: Hemoglobin in the experimental group
Description
Hemoglobin will be measured in g/L
Time Frame
Month 3
Title
Complete blood count: Hemoglobin in the control group
Description
Hemoglobin will be measured in g/L
Time Frame
Month 3
Title
Complete blood count: Hematocrit in the experimental group
Description
Hematocrit will be measured as a % of whole blood
Time Frame
Month 0
Title
Complete blood count: Hematocrit in the control group
Description
Hematocrit will be measured as a % of whole blood
Time Frame
Month 0
Title
Complete blood count: Hematocrit in the experimental group
Description
Hematocrit will be measured as a % of whole blood
Time Frame
Month 3
Title
Complete blood count: Hematocrit in the control group
Description
Hematocrit will be measured as a % of whole blood
Time Frame
Month 3
Title
Complete blood count: Platelets in the experimental group
Description
Platelets will be measured in K/µL
Time Frame
Month 0
Title
Complete blood count: Platelets in the control group
Description
Platelets will be measured in K/µL
Time Frame
Month 0
Title
Complete blood count: Platelets in the experimental group
Description
Platelets will be measured in K/µL
Time Frame
Month 3
Title
Complete blood count: Platelets in the control group
Description
Platelets will be measured in K/µL
Time Frame
Month 3
Title
T-lymphocytes in the experimental group
Description
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Time Frame
Month 0
Title
T-lymphocytes in the control group
Description
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Time Frame
Month 0
Title
T-lymphocytes in the experimental group
Description
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Time Frame
Month 3
Title
T-lymphocytes in the control group
Description
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Time Frame
Month 3
Title
Monocytes in the experimental group
Description
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Time Frame
Month 0
Title
Monocytes in the control group
Description
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Time Frame
Month 0
Title
Monocytes in the experimental group
Description
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Time Frame
Month 3
Title
Monocytes in the control group
Description
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Time Frame
Month 3
Title
Aspartate aminotransferase (ASAT) in the experimental group
Description
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Time Frame
Month 0
Title
Aspartate aminotransferase (ASAT) in the experimental group
Description
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Time Frame
Month 3
Title
Aspartate aminotransferase (ASAT) in the control group
Description
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Time Frame
Month 0
Title
Aspartate aminotransferase (ASAT) in the control group
Description
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Time Frame
Month 3
Title
Alanine aminotransferase (ALAT) in the experimental group
Description
Alanine aminotransferase (ALAT) will be measured in international units per liter
Time Frame
Month 0
Title
Alanine aminotransferase (ALAT) in the experimental group
Description
Alanine aminotransferase (ALAT) will be measured in international units per liter
Time Frame
Month 3
Title
Alanine aminotransferase (ALAT) in the control group
Description
Alanine aminotransferase (ALAT) will be measured in international units per liter
Time Frame
Month 0
Title
Alanine aminotransferase (ALAT) in the control group
Description
Alanine aminotransferase (ALAT) will be measured in international units per liter
Time Frame
Month 3
Title
Alkaline phosphatase in the experimental group
Description
Alkaline phosphatase (ALP) will be measured in units per liter
Time Frame
Month 0
Title
Alkaline phosphatase in the experimental group
Description
Alkaline phosphatase (ALP) will be measured in units per liter
Time Frame
Month 3
Title
Alkaline phosphatase in the control group
Description
Alkaline phosphatase (ALP) will be measured in units per liter
Time Frame
Month 0
Title
Alkaline phosphatase in the control group
Description
Alkaline phosphatase (ALP) will be measured in units per liter
Time Frame
Month 3
Title
Calcium in the experimental group
Description
Calcium will be measured in mmol/L
Time Frame
Month 0
Title
Calcium in the experimental group
Description
Calcium will be measured in mmol/L
Time Frame
Month 3
Title
Calcium in the control group
Description
Calcium will be measured in mmol/L
Time Frame
Month 0
Title
Calcium in the control group
Description
Calcium will be measured in mmol/L
Time Frame
Month 3
Title
Creatinine in the experimental group
Description
Calcium will be measured in μmol/L
Time Frame
Month 0
Title
Creatinine in the experimental group
Description
Calcium will be measured in μmol/L
Time Frame
Month 12
Title
Creatinine in the control group
Description
Calcium will be measured in μmol/L
Time Frame
Month 0
Title
Creatinine in the control group
Description
Calcium will be measured in μmol/L
Time Frame
Month 12
Title
Albumin in the experimental group
Description
Albumin will be measured in g/liter
Time Frame
Month 0
Title
Albumin in the experimental group
Description
Albumin will be measured in g/liter
Time Frame
Month 12
Title
Albumin in the control group
Description
Albumin will be measured in g/liter
Time Frame
Month 0
Title
Albumin in the control group
Description
Albumin will be measured in g/liter
Time Frame
Month 12
Title
Urea in the experimental group
Description
Urea will be measured in mmol/L
Time Frame
Month 0
Title
Urea in the experimental group
Description
Urea will be measured in mmol/L
Time Frame
Month 12
Title
Urea in the control group
Description
Urea will be measured in mmol/L
Time Frame
Month 0
Title
Urea in the control group
Description
Urea will be measured in mmol/L
Time Frame
Month 12
Title
Bilirubin in the experimental group
Description
Bilirubin will be measured in µmol/L
Time Frame
Month 0
Title
Bilirubin in the experimental group
Description
Bilirubin will be measured in µmol/L
Time Frame
Month 12
Title
Bilirubin in the control group
Description
Bilirubin will be measured in µmol/L
Time Frame
Month 0
Title
Bilirubin in the control group
Description
Bilirubin will be measured in µmol/L
Time Frame
Month 12
Title
C-Reactive Protein in the experimental group
Description
C-Reactive Protein will be measured in mg/L
Time Frame
Month 0
Title
C-Reactive Protein in the experimental group
Description
C-Reactive Protein will be measured in mg/L
Time Frame
Month 12
Title
C-Reactive Protein in the control group
Description
C-Reactive Protein will be measured in mg/L
Time Frame
Month 0
Title
C-Reactive Protein in the control group
Description
C-Reactive Protein will be measured in mg/L
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with spondyloarthritis meeting the ASAS criteria Patient considered by the treating rheumatologist for anti-IL-17 biomedication Patients aged between 18 and 90 years of age Patients who are affiliated to a French social security system or beneficiaries of such a system Patients with no desire to become pregnant during the study period (Effective contraception for women of childbearing age during the study period (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device)) Exclusion Criteria: Lack of written informed consent after a time of reflection Patients participating in other therapeutic research or having participated in research for which the exclusion period has not ended Patient under court protection, guardianship or curatorship. Patient unable to give consent. Pregnant or breastfeeding woman Patients with digestive disorders for which a chronic inflammatory bowel disease has not been excluded Patients with fructose intolerance or glucose or galactose malabsorption Patients with known intolerance to inulin or maltodextrin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cédric LUKAS, Professor
Phone
+334 67 33 87 10
Email
c-lukas@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anissa MEGZARI
Phone
+33466684236
Email
drc@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cédric LUKAS, Professor
Organizational Affiliation
Montpellier University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jacques MOREL, Professor
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire DAIEN, Professor
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaël MOUTERDE, Doctor
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cécile GAUJOUX-VIALA, Professor
Organizational Affiliation
Nîmes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denis MULLEMAN, Professor
Organizational Affiliation
Tours University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillermo CARVAJAL, Doctor
Organizational Affiliation
Tours University Hospital
Official's Role
Principal Investigator
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
Cecile GAUJOUX-VIALA, Pofessor
Email
cecile.GAUJOUX.VIALA@chu-nimes.fr
Facility Name
Montpellier University Hospital
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric LUKAS, Professor
Phone
+33467337791
Email
c-lukas@chu-montpellier.fr
Facility Name
Tours Regional University Hospital (Bretonneau)
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37032
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis MULLEMAN, Professor
Phone
+33247366368
Email
denis.mulleman@univ-tours.fr

12. IPD Sharing Statement

Learn more about this trial

Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17

We'll reach out to this number within 24 hrs