Evaluating Fecal Microbiota Transplant and Anti-Inflammatory Diet with 5-ASA for Treating Mild to Moderate Active Ulcerative Colitis in Adults

What this Trial Is About

Ulcerative colitis UC is a chronic inflammatory disease affecting the colon and rectum, causing symptoms like diarrhea, abdominal pain, and rectal bleeding. It involves immune system problems and changes in gut bacteria. This research aims to study how fecal microbiota transplantation FMT and an anti-inflammatory diet, alone or combined, affect disease activity in patients with mild to moderate active UC who have not received treatment before. The trial is designed as a multi-center, double-blind, randomized study with a 2x2 factorial design to test different treatment combinations alongside standard medication. Participants are randomly assigned to one of four groups FMT with anti-inflammatory diet plus 5-aminosalicylic acid 5-ASA FMT with sham diet plus 5-ASA sham transplantation with anti-inflammatory diet plus 5-ASA or sham transplantation with sham diet plus 5-ASA. FMT is given via colonoscopy at weeks 0, 2, and 6 during the induction phase, with maintenance doses every 8 weeks up to 48 weeks for responders. The anti-inflammatory diet excludes certain foods and promotes others to support gut health. Sham treatments include sterile water infusions and dietary counseling without changes. During the study, participants undergo clinical evaluations, endoscopy, histology, and laboratory tests at baseline, 10 weeks, and 48 weeks. Researchers assess clinical remission, endoscopic response, and other outcomes to understand treatment effects. Safety is monitored through adverse event reporting. The trial lasts about 48 weeks for each participant, with ongoing assessments of disease activity, gut microbiome changes, and treatment response.

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis