Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT05812157

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-05-09

36

Participants Needed

3

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with spondyloarthritis meeting the ASAS criteria
  • Patients planned for anti-IL-17 biomedication by their rheumatologist
  • Aged between 18 and 90 years
  • Affiliated with the French social security system or beneficiaries
  • Women of childbearing age must use effective contraception or have no desire to become pregnant during the study period
Not Eligible

You will not qualify if you...

  • No written informed consent provided
  • Participation in other therapeutic research with ongoing exclusion period
  • Under court protection, guardianship, or curatorship
  • Unable to give consent
  • Pregnant or breastfeeding
  • Digestive disorders without exclusion of chronic inflammatory bowel disease
  • Fructose intolerance or glucose/galactose malabsorption
  • Known intolerance to inulin or maltodextrin

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Nîmes University Hospital

Nîmes, Gard, France, 30029

Actively Recruiting

2

Montpellier University Hospital

Montpellier, Hérault, France, 34000

Actively Recruiting

3

Tours Regional University Hospital (Bretonneau)

Tours, Indre-et-Loire, France, 37032

Actively Recruiting

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Research Team

C

Cédric LUKAS, Professor

CONTACT

A

Anissa MEGZARI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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