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

NCT05812157 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-05-09

No results posted yet for this study

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.

Conditions

  • Axial Spondyloarthritis

Interventions

DIETARY_SUPPLEMENT

Daily dietary supplementation with Fibruline

Supplementation with 12 grams per day of Fibruline reconstituted with 60mL of water, once a day

DRUG

Anti-IL-17 therapy

Patients in both groups will be on anti-IL-17 therapy

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Cédric LUKAS, Professor · Montpellier University Hospital

  • Jacques MOREL, Professor · Montpellier University Hospital

  • Claire DAIEN, Professor · Montpellier University Hospital

  • Gaël MOUTERDE, Doctor · Montpellier University Hospital

  • Cécile GAUJOUX-VIALA, Professor · Nîmes University Hospital

  • Denis MULLEMAN, Professor · Tours University Hospital

  • Guillermo CARVAJAL, Doctor · Tours University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812157 on ClinicalTrials.gov