DOI: 10.1101/19011635Nov 12, 2019Paper

Re-evaluating the evidence for fecal microbiota transplantation "super-donors" in inflammatory bowel disease

MedRxiv : the Preprint Server for Health Sciences
Scott W Olesen, Ylaine Gerardin

Abstract

Fecal microbiota transplantation (FMT) is a recommended treatment for recurrent Clostridioides difficile infection, and there is promise that FMT may be effective for conditions like inflammatory bowel disease (IBD). Previous FMT clinical trials have considered the possibility of a "donor effect", that is, that FMT material from different donors has different clinical efficacies. Here we lay out rigorous statistical methodology for detecting donor effects, finding that reliable detection of a donor effect requires trials with more than 200 FMT-treated patients. A re-evaluation of previous FMT clinical trials for IBD showed that while there is very little evidence for a non-zero donor effect, the existing data are also not inconsistent with substantial donor effects. Large-scale meta-analysis, combined with careful reporting from clinical trials, will be crucial in determining if donor effects are clinically relevant for IBD.

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