Evaluation of Rectal Administration of a Specific Probiotic to Improve Gut Health in Adults with Mild-to-Moderate Ulcerative Colitis

What this Trial Is About

Researchers are studying the effect of a specific probiotic delivered rectally in adults with mild-to-moderate ulcerative colitis, a condition where the gut microbiota is imbalanced. Traditional probiotics come from fermented foods and have a long history of safe use but are not designed to treat diseases. This study explores next-generation probiotics, newly identified gut microbes with potential therapeutic benefits, even though they lack extensive safety history. Participants will receive a rectal administration of a specific probiotic to evaluate its impact on gut health and rectal mucosal healing. The study also involves diagnostic tests including collection of biopsies. This probiotic is being assessed for its tolerability and feasibility over a 1-year period. The study is designed as a single group intervention without placebo comparison. During the study, participants will undergo evaluations including endoscopic and histopathologic assessments, biopsies, and monitoring of disease activity using the Modified Mayo Score. Researchers will assess rectal mucosal healing, quality of life, and probiotic tolerability. Participants must provide informed consent and comply with scheduled assessments throughout the study, which aims to last up to 2 years including follow-up. Safety monitoring excludes those with infections or recent use of certain therapies.

A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis