Abstract
Results of the First Pilot Randomized Controlled Trial of Fecal Microbiota Transplant In Pediatric Ulcerative Colitis: Lessons, Limitations, and Future Prospects
Highlights
The incidence of childhoodonset inflammatory bowel disease (IBD) has increased significantly over the past decade.[1]
Patients were randomized to fecal microbiota transplant (FMT) (n 1⁄4 13) or placebo (n 1⁄4 12) arms; 46% of patients in the trial were diagnosed with ulcerative colitis (UC) for less than 1 year
We found a higher proportion of serious adverse events (SAEs) in patients receiving active (FMT) treatment, which has not been demonstrated across other trials.[4]
Summary
The incidence of childhoodonset inflammatory bowel disease (IBD) has increased significantly over the past decade.[1]. Our pilot feasibility protocol has been reported previously.[14] We discuss our findings and experience conducting the Pediatric FEcal microbiota Transplant in ulcerative Colitis (PediFETCh) Trial and important lessons that may support future investigators. Challenges Associated With Recruitment to Pediatric Fecal Microbiota Transplant Trials
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