MEDIBIOTE 3 Study on How Gut Microbiota Predicts Response to Biotherapy in Spondyloarthritis

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-TNF 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-TNF 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.

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