Fecal microbiota transplantation (FMT), which is up to 90% effective in treating recurrent Clostridium difficile (C. difficile) infection, may or may not be an effective treatment for other conditions. Researchers around the world are investigating its use for ulcerative colitis, Crohn’s disease, and more. Regulatory bodies have not approved its use for conditions other than C. difficile, but that doesn’t stop thousands of people from trying FMT at home. An estimated 10,000 people per year are doing FMT without permission and without supervision, according to Catherine Duff, founder and president of patient advocacy organization The Fecal Transplant Foundation. Journalist David Wild recently spoke with Duff and reported that individuals are self-administering FMT for conditions as diverse as Crohn’s disease and ulcerative colitis, autism, depression, diabetes, and multiple sclerosis.
Wild highlights the public health problem that arises from widespread ‘DIY’ FMT procedures, since the safety of FMT for conditions other than C. difficile has not been established. Scientists don’t yet know the extent to which FMT may transfer harmful bacteria, viruses, and parasites. Research is urgently needed, because so far reports of at-home procedures outnumber those in scientific studies. The credibility of FMT as a science-based treatment may be at stake.
Researchers who seek to investigate FMT in a clinical trial for a non–C. diff indication must deal with administrative barriers; even after a researcher gains approval to study FMT for a condition other than C. difficile, it typically takes a long time to gather the resources and produce the data.
Mark Smith of OpenBiome stool bank (which supplies hospitals with screened samples for use with C. difficile patients) emphasizes the possible dangers of unsupervised at-home FMT. His nonprofit organization supports research-backed uses of FMT, to minimize risk and maximize treatment efficacy.
Jessica Richman, co-founder of uBiome, agrees that the problem needs to be addressed with more studies. “[Research is often] stuck in this paradigm that’s very much a ‘cottage industry’ where one person knows how to do one kind of study,” she says. This is where she thinks uBiome — as a producer of microbiome research data — can possibly play a role in accelerating research studies on FMT.
Richman, whose company plays matchmaker between research subjects and scientists, sees citizen science as a valuable way to advance new clinical applications like FMT. “[We] do these research collaborations that will lead to specific clinical applications and try to speed up that process by having more people sampled, more people involved in the process… and then to iterate more quickly than is traditional in the biotech world.”
Richman emphasizes it is best for people who do FMT to participate in a bona fide trial. “If you’re part of a research study, there will be a research protocol and everyone will have to follow the same protocol, which will lead to better results.”
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