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Clinical Trials in France / NCT04899154
Recruiting Not applicable

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

NCT04899154 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2019-07-16
Last updated
2025-09-25

Condition(s) studied

Spondyloarthritis

Investigational drug(s) / intervention(s)

stool samplingstool sampling

stool sampling: Participants will provide two stool samples: one collected the day of inclusion and a second, four months later after anti-TNF α or anti- IL-17 (interleukin-17) treatment initiation.

stool sampling: Participants will provide one stool sample at inclusion

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: For patient with spondyloarthritis: * Diagnosed for spondyloarthritis or pure axial or axial type psoriatic rheumatism according to Assessment of Spondyloarthritis International Society (ASAS) criteria. * Requiring treatment with anti-TNFα or anti- IL-17 according to the treatment recommendations of the French Society of Rheumatology (SFR) * patient not previously treated with biotherapy * Aged ≥ 18 years * Having given free and informed written consent * Being affiliated to the center national security system social For control Subject: * Healthy volunteers without diagnosis of spondyloarthritis or any other chronic disease. * Aged ≥ 18 years * Having given free and informed written consent * Being affiliated with or benefiting from a social security scheme. Exclusion Criteria: * Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within one month before stool sampling. * Association with another chronic pathology

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Européen Marseille Marseille France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04899154 on ClinicalTrials.gov ↗ ← All trials in France