Fecal microbiota transplantation: Uses, questions, and ethics

Fecal microbiota transplantation (FMT) has rapidly grown in notoriety and popularity worldwide as a treatment for both recurrent and refractory C. difficile infection (CDI), as well as for a myriad of other indications, with varying levels of evidence to justify its use. At present, FMT use in the U...

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Bibliographic Details
Published in:Medicine in microecology 2020-12, Vol.6, p.100027, Article 100027
Main Authors: Grigoryan, Zoya, Shen, Michael J., Twardus, Shaina W., Beuttler, Marc M., Chen, Lea Ann, Bateman-House, Alison
Format: Article
Language:English
Subjects:
Bioethics
C. difficile
Expanded access
Gastrointestinal microbiome
Investigational drugs
Regulation
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Summary:Fecal microbiota transplantation (FMT) has rapidly grown in notoriety and popularity worldwide as a treatment for both recurrent and refractory C. difficile infection (CDI), as well as for a myriad of other indications, with varying levels of evidence to justify its use. At present, FMT use in the U.S. has not received marketing approval from the U.S. Food and Drug Administration (FDA), but is permitted under “enforcement discretion” for CDI not responding to standard therapy. Meanwhile, the rising interest in the gut microbiome throughout mainstream media has paved the way for “do-it-yourself” (DIY) adaptations of the procedure. This access and unregulated use, often outside any clinical supervision, has quickly outpaced the medical community's research and regulatory efforts. While some studies have been able to demonstrate the success of FMT in treating conditions other than CDI—studies on ulcerative colitis have been particularly promising—little is still known about the treatment's mechanism of action or long-term side effects. Likewise, screening of donor stool is in its early stages in terms of protocol standardization. In this paper, we explore the regulatory and ethical concerns that arise from the need to balance access to a nascent but promising innovative treatment with the need for research into its efficacy, risk profile, and long-term impact. •Fecal Microbiota Transplantation (FMT) is a therapy growing in popularity worldwide.•However, little is known about its mechanism of action or long-term side effects.•Balancing access and research into FMT introduces regulatory and ethical concerns.
ISSN:2590-0978
2590-0978
DOI:10.1016/j.medmic.2020.100027