Gut bacteria test to predict response to biologic treatment in spondyloarthritis
Official title: MEDIBIOTE 3: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy
Run by Hôpital Européen Marseille · NCT04899154 · Data updated 2026-11-12
This project will test whether gut bacteria in stool samples can predict if anti-TNF or anti-IL-17 biologic treatment will work for adults with spondyloarthritis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Hôpital Européen Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | July 16, 2019 |
| Main results expected | May 15, 2026 |
| Study ends | May 15, 2026 |
| Registry record updated | September 25, 2025 |
| Trial ID | NCT04899154 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with spondyloarthritis who are biologic‑naïve and about to start anti‑TNFα or anti‑IL‑17 therapy, able to give informed consent and without recent antibiotic or probiotic use, are ideal candidates.
✕Probably not a fit
Patients already treated with biologics, those who recently used antibiotics, probiotics, or prebiotics, and people with other chronic diseases may not be eligible or may not benefit from the predictive microbiota findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center prospective study will collect baseline stool samples from adults with spondyloarthritis who are starting anti-TNFα or anti-IL-17 biologic therapy and from healthy control volunteers. Microbiota composition will be analyzed and compared with clinical response after treatment initiation to see if specific bacterial patterns predict who responds. Eligible patients must be biologic‑naïve and must not have used antibiotics, probiotics, or prebiotics in the month before sampling to avoid confounding. The study is conducted at Hôpital Européen in Marseille with scheduled clinical follow-up to determine treatment response.
Why it matters
Potential benefit: If successful, this approach could help doctors choose the biologic most likely to work for a patient, reducing ineffective treatments and speeding clinical improvement.
How similar studies have gone: Several prior studies have reported microbiota differences in spondyloarthritis and a small uncontrolled study suggested gut profiles might predict anti‑TNF response, but prospective confirmation is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hôpital Européen Marseille
Marseille, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.