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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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))

Locations
Other Locations
France
Montpellier University Hospital
RECRUITING
Montpellier
Nîmes University Hospital
RECRUITING
Nîmes
Tours Regional University Hospital (Bretonneau)
RECRUITING
Tours
Contact Information
Primary
Cédric LUKAS, Professor
c-lukas@chu-montpellier.fr
+334 67 33 87 10
Backup
Anissa MEGZARI
drc@chu-nimes.fr
+33466684236
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 36
Treatments
Experimental: Experimental group
Patients with aSp receiving fiber supplements in the form of Fibruline® Instant (Fagron laboratories)
Placebo_comparator: Control group
Patients with aSp receiving fake fiber supplements (placebo) in the form of Maltodextrine (laboratoire Fagron).
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov