Improving treatment for axial spondyloarthritis with fiber supplementation
Optimization of Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17
NA · Centre Hospitalier Universitaire de Nīmes · NCT05812157
This study is testing if adding fiber supplements to the usual anti-IL-17 treatment can help people with axial spondyloarthritis feel better by improving their gut health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes (other) |
| Locations | 3 sites (Nîmes, Gard and 2 other locations) |
| Trial ID | NCT05812157 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of dietary fiber supplementation on patients with axial spondyloarthritis (AxSpA) who are undergoing anti-IL-17 therapy. The approach focuses on correcting treatment-aggravated gut dysbiosis, which may hinder the effectiveness of anti-IL-17 medications. By enhancing the composition of the gut microbiota and increasing the production of short-chain fatty acids (SCFAs), the study aims to improve the immune response and overall treatment outcomes for AxSpA patients. Participants will receive daily fiber supplementation alongside their standard anti-IL-17 treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 90 with axial spondyloarthritis who are being considered for anti-IL-17 therapy.
Not a fit: Patients with chronic inflammatory bowel diseases or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the therapeutic response to anti-IL-17 treatments in patients with axial spondyloarthritis.
How similar studies have performed: While the specific combination of fiber supplementation with anti-IL-17 therapy is novel, previous studies have shown that dietary interventions can positively influence gut microbiota and inflammatory responses.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nîmes, Gard and 2 other locations
- Nîmes University Hospital — Nîmes, Gard, France (RECRUITING)
- Montpellier University Hospital — Montpellier, Hérault, France (RECRUITING)
- Tours Regional University Hospital (Bretonneau) — Tours, Indre-et-Loire, France (RECRUITING)
Study contacts
- Principal investigator: Jacques MOREL, Professor — Montpellier University Hospital
- Study coordinator: Cédric LUKAS, Professor
- Email: c-lukas@chu-montpellier.fr
- Phone: +334 67 33 87 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Axial Spondyloarthritis, dysbiosis, short-chain fatty acids, fiber, microbiota