This is the first study of its kind to compare fecal transplant to the current standard of care for RCDI.
Researchers at the University Health Network have found that when treating recurrent Clostridium difficile infection (RCDI), a single fecal transplantation delivered by enema is no more effective than the existing standard of care for RCDI, administration of oral vancomycin taper. The findings were published recently in the journal Clinical Infectious Diseases.
Over the last decade, FT has re-emerged as a promising treatment for RCDI with recent studies showing it to be highly effective. In an effort to measure the true effectiveness of FT, the UHN team launched a phase 2/3, single centre, open-label trial, where study participants experiencing an acute episode of RCDI were randomly assigned to receive either 14 days of oral vancomycin therapy followed by a single FT of fresh donor stool via enema, or a six week taper of oral vancomycin only.
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The team terminated the study since they found no significant difference between the treatments. In fact, a futility analysis showed that should the study have been completed, it is highly unlikely that FT would show benefit over oral vancomycin taper. This is the first study of its kind to compare FT to the current standard of care for RCDI.
“In light of our results, I would caution a blanket approach of FT to treat RCDI,” says Dr. Hota. “The FT field is still evolving and, given as yet undefined long-term effects of manipulating the gut’s microbiota, it should be approached with caution,” says Dr. Susy Hota, Medical Director, Infection Prevention and Control Program.
In an effort to provide more data about the long term health effects of FT, Dr. Hota, co-lead Dr. Susan Poutanen and colleagues at UHN, Sinai Health System and the University of Toronto founded the Microbiota Therapeutics Outcomes Program (MTOP). A multi-disciplinary, collaborative research program, the MTOP is conducting studies to measure long term health outcomes from FT when it is used to treat C. diff and several other health conditions.View full press release.