At a glance
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A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified
In Brief
A Phase 1 clinical trial evaluating Fecal Microbiota Enema and Normal Saline Enema for Inflammatory Bowel Disease and Ulcerative Colitis. Completed, enrolled 35 participants across 3 sites.
Detailed Summary
The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbiota transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory bowel disease-unclassified (IBD-U). Investigators will test the hypothesis that a protocol of twice-weekly retention enemas delivered over six weeks, using fecal transplant material from a healthy donor, will improve clinical and biological disease markers in patients with pediatric UC or IBD-U.
Study Details
Timeline
Interventions
Active intervention.
Placebo comparator.