Clinical trial

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

Name
IDRCB : 2022-A00135-38
Description
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.
Trial arms
Trial start
2023-10-02
Estimated PCD
2026-12-01
Trial end
2026-12-01
Status
Recruiting
Treatment
Daily dietary supplementation with Fibruline
Supplementation with 12 grams per day of Fibruline reconstituted with 60mL of water, once a day
Arms:
Control group, Experimental group
Anti-IL-17 therapy
Patients in both groups will be on anti-IL-17 therapy
Arms:
Control group, Experimental group
Size
36
Primary endpoint
Clostridial changes in the Experimental group
Week 0
Clostridial changes in Controls
Week 0
Clostridial changes in the Experimental group
Week 12
Clostridial changes in Controls
Week 12
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, double-blind, prospective, randomized controlled study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}
Updated at
2023-10-04

1 organization

1 product

1 indication