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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Mar 31, 2023

Keywords

ClinConnect Summary

The RESPOND-IL17 clinical trial is studying how adding fiber to the diet of patients with axial spondyloarthritis (AxSpA) can improve their response to a specific treatment called anti-IL-17 therapy. Fiber is important because it helps support healthy gut bacteria, which can become imbalanced during treatment. By improving the gut’s bacteria balance, the study hopes to enhance the immune system's response and alleviate symptoms of AxSpA.

To join the trial, participants need to be between 18 and 90 years old and diagnosed with spondyloarthritis. They must also be considered by their doctor for anti-IL-17 medication and agree to use effective contraception if they are women of childbearing age. Participants can expect to incorporate fiber supplements into their diet while monitoring how this affects their condition. It’s important to note that those with certain digestive disorders or specific intolerances will not be eligible. This trial is currently recruiting participants, and it aims to provide valuable insights into improving treatment for AxSpA patients.

Gender

ALL

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