Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04899154

Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

Led by Hôpital Européen Marseille · Updated on 2025-09-25

80

Participants Needed

1

Research Sites

356 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated. Several studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota. The purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα / anti-IL17).

CONDITIONS

Official Title

Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with spondyloarthritis or axial type psoriatic arthritis according to ASAS criteria
  • Require treatment with anti-TNF alpha or anti-IL-17 as recommended by the French Society of Rheumatology
  • Have not received biotherapy previously
  • Aged 18 years or older
  • Provided free and informed written consent
  • Affiliated with the national social security system
  • Healthy volunteers without spondyloarthritis or other chronic diseases
  • Aged 18 years or older
  • Provided free and informed written consent
  • Affiliated with or benefiting from a social security scheme
Not Eligible

You will not qualify if you...

  • Treated with antibiotics, probiotics, prebiotics, or any treatment affecting gut microbiota within one month before stool sampling
  • Have another chronic disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Européen Marseille

Marseille, France

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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