NCT05812157Completed
Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17
Optimization of Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 31 Mar 2023
- Start date
- 2 Oct 2023
- Primary completion date
- 23 Feb 2026
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT05812157
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 2 Oct 2023 to the primary completion date, 23 Feb 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with digestive disorders for which a chronic inflammatory bowel disease has not been excluded
Lab values
- Patients with fructose intolerance or glucose or galactose malabsorption
Other
- 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 known intolerance to inulin or maltodextrin
Who the study is looking for
- 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))
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montpellier University Hospital Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Nîmes University Hospital Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Tours Regional University Hospital (Bretonneau) Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.