Clinical Trial

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

Study acronym: MEDIBIOTE 3
Recruiting
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Record status
This record was last updated September 25, 2025 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-05-19; most recent amendment 2025-09-24.
Trial Details
NCT Number NCT04899154
Lead Sponsor Hôpital Européen Marseille
Conditions Spondyloarthritis
Enrollment 80 participants
Start Date 2019-07-16
Primary Completion 2026-05-15 (estimated)
Study Completion 2026-05-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-25