McMaster University

McMaster University

The Pedi FETCh Research Trial

The Pedi FETCh Research Trial: Pediatric Fecal Transplant for Ulcerative Colitis (FETCh)

The Pedi FETCh Research Trial (Pediatric Fecal Transplant for Ulcerative Colitis) is the first pediatric fecal transplant study for inflammatory bowel disease in Canada, and will be the first randomized controlled trial of fecal transplant in pediatric inflammatory bowel disease in the world. The trial is being lead by Dr. Nikhil Pai, and supported by the Division of Pediatric Gastroenterology and Nutrition at McMaster Children’s Hospital. Study collaborators include Dr. Christine Lee (Division of Infectious Disease at St. Joseph's Hospital in Hamilton), and Paul Moayyedi (Division of Adult Gastroenterology at McMaster University), with support from the Farncombe Digestive Disease Research Institute at McMaster University.

Safety Monitoring

The fecal transplant materials come from live human donor stool that has been extensively screened for bacteria, viruses and blood-borne pathogens at multiple time points prior to administration. We have partnered with Rebiotix®, a biotechnology company that has received FDA and Health Canada approval to use its fecal enemas for treatment of Clostridium difficile colitis, a highly infectious bacteria that can be effectively treated with fecal transplant. This trial will use the same, FDA and Health Canada approved enema preparation, as a potentially new treatment of pediatric inflammatory bowel disease.

Throughout the trial, patients’ disease activity will be measured weekly.

Blood work and fecal calprotectin levels will be monitored at multiple time points and the primary doctor will be copied on all blood work if there are any concerns at any time.

Patients are able to withdraw from the study at any time, and we will enforce strict safety monitoring guidelines to remove patients from the study if there are adverse events.

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