Researchers are performing the first ever randomized controlled trial of fecal transplants in children with ulcerative colitis at McMaster University in Canada, according to a press release.
“The PediFETCh study will help determine — for the first time — whether fecal transplants can be a viable treatment for children with UC who cannot control their disease with their current medications, or who want to avoid moving onto higher doses, different medications, or surgery,” Nikhil Pai, MD, pediatric gastroenterologist at the Center for Child and Youth Digestive Health at McMaster Children’s Hospital, and assistant professor of pediatrics at McMaster University’s Michael G. DeGroote School of Medicine, said in the press release. “This is a potentially life-changing treatment option for kids and teens affected by this increasingly common disease.”
Previous research has shown fecal transplants benefit adults with IBD, but this single blind, placebo-controlled trial will recruit patients aged 6 to 17 years with active ulcerative colitis or unclassified IBD.
While continuing their current medication regimens, patients will receive a fecal retention enema containing screened donor stool or normal saline placebo twice a week for 6 weeks, and their disease activity will be measured weekly, according to McMaster’s website. The trial will use FDA- and Health Canada-approved fecal enema preparations from Rebiotix.
Christine Lee, MD, of the division of infectious disease at St. Joseph’s Hospital in Hamilton, Ontario, Paul Moayyedi, MD, of the division of adult gastroenterology at McMaster University, and Jelena Popov, research coordinator, will collaborate with Pai, and the Farncombe Family Digestive Health Research Institute at McMaster University will provide study support.
The province of Ontario, where the trial will take place, has one of the highest rates of childhood-onset IBD in the world, according to the press release.
Disclosures: Healio Gastroenterology was unable to confirm the researchers' relevant financial disclosures at the time of publication.