Daily Oral Microbiome-Targeted Supplement Versus Placebo for Adults With Mild-to-Moderate Active Ulcerative Colitis

What this Trial Is About

Researchers are evaluating a once-daily oral microbiome-targeted food supplement compared with a matching placebo in adults with mild-to-moderate, active ulcerative colitis. This Phase 2b randomized, double-blind, placebo-controlled trial aims to determine if the supplement can increase the proportion of patients achieving clinical and biochemical remission by Week 24. The trial is conducted across multiple university hospital centers in Turkey with approximately 162 participants. Participants will be randomly assigned to receive either the microbiome-targeting supplement or a placebo once daily for 24 weeks. Both groups will continue their stable background therapy with 5-aminosalicylic acidmesalamine or no inflammatory bowel disease treatment, depending on eligibility. Rescue therapy or treatment escalation is allowed if clinically necessary during the trial. Throughout the study, participants will undergo regular assessments including flexible sigmoidoscopy at Week 24, stool and blood sample collections for biomarker and microbiome analyses, and questionnaires to evaluate symptoms and quality of life. Safety is closely monitored with scheduled reviews by an independent board. The primary outcome is the proportion of participants achieving combined clinical and biochemical remission at Week 24, with multiple secondary outcomes also evaluated.

AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis