Actively Recruiting
MEDIBIOTE 3: 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Spondyloarthritis (SpA) is a group of inflammatory rheumatic diseases that cause pain mainly in the spine, pelvis, and sometimes limbs. This research aims to confirm whether the makeup of the gut microbiota before starting treatment can predict how patients with SpA respond to biotherapy treatments like anti-TNFα or anti-IL-17. Earlier studies suggested a link between gut microbiota changes and treatment response, but this study focuses on verifying those findings. Participants in the study include patients diagnosed with SpA or axial psoriatic rheumatism who need biotherapy treatment and healthy volunteers without chronic diseases. Patients will provide stool samples twice: once at the start and again four months after beginning treatment with anti-TNFα or anti-IL-17. Healthy volunteers will provide one stool sample at inclusion. The study is non-randomized and does not use blinding. During the 18-month study period, researchers will analyze the gut microbiota composition qualitatively and quantitatively to compare patients who respond to biotherapy with those who do not, as well as with healthy controls. Participants will provide stool samples and undergo evaluations to track changes in their intestinal microbiota. The main outcome is the variability in gut microbiota composition related to treatment response, monitored over 18 months.
CONDITIONS
Brief Title
Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with spondyloarthritis or axial psoriatic rheumatism according to ASAS criteria
- Requiring treatment with anti-TNFα or anti-IL-17 as per French Society of Rheumatology recommendations
- Not previously treated with biotherapy
- 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
You will not qualify if you...
- Treated with antibiotics, probiotics, prebiotics, or other treatments affecting gut microbiota within one month before stool sampling
- Having another chronic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants provide stool samples to analyze intestinal microbiota before and after starting biotherapy treatment.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Hôpital Européen Marseille
Marseille, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here