Evaluating Fecal Microbial Transplant and Crohns Disease Exclusion Diet with Advanced Therapies for Active Crohns Disease A Multi-Center Double-Blind Randomized Trial

What this Trial Is About

Researchers are investigating new ways to improve treatment for active Crohns Disease CD, a complex inflammatory bowel condition. This study focuses on whether combining advanced therapies like biologics and small molecules with microbiome-based treatmentsfecal microbiota transplantation FMT and a special diet called Crohns Disease Exclusion Diet CDEDcan overcome the limits of current treatments. The trial is a multicenter, double-blind, randomized controlled study designed to provide strong scientific evidence on these combined approaches. Participants in the study will be assigned to one of four groups receiving different combinations of treatments FMT via colonoscopy at specified weeks, CDED diet, sham FMT using sterile water, or sham diet counseling, all alongside standard advanced therapies. FMT is given during an induction phase weeks 0, 2, and 6 and, for responders, every eight weeks during maintenance up to week 42. The CDED involves eliminating certain pro-inflammatory foods initially, then gradually reintroducing some foods during maintenance. Sham treatments mimic the procedures without the active components, ensuring the study remains double-blinded. Throughout the study, participants will undergo regular assessments including clinical activity scores, symptom tracking, blood and stool tests, endoscopic evaluations, and microbiome analysis. Visits occur frequently during induction and maintenance phases, with safety monitoring before and after FMT sessions. The main outcomes measured are the rates of clinical remission and endoscopic response at weeks 10 and 48. This comprehensive approach aims to understand how these combined therapies affect disease activity and patient health over nearly a year of follow-up.

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies