Fecal microbiota transplantation: the evolving risk landscape
File(s)
Accepted version
Author(s)
Gupta, Sanchit
Mullish, Benjamin H
Allegretti, Jessica R
Type
Journal Article
Abstract
Fecal microbiota transplantation (FMT) has been recommended in clinical guidelines for the treatment for recurrent Clostridioides difficile infection (CDI). However, it is considered investigational by most regulatory agencies. As the adoption of FMT increased from a small group of CDI experts alone to more widespread use, there has been a corresponding increase in concern regarding potential risk. FMT is largely considered a safe procedure, though risks described range from mild gastrointestinal symptoms to serious infection. Currently, there is variability in how ‘FMT’ is characterized specifically with regards to testing approach, which, in turn, impacts the risk profile. This has been highlighted by the rare cases of multidrug-resistant organisms, Shiga toxin-producing E. coli and enteropathogenic E. coli recently reported, where these organisms were not screened. These cases have prompted additional screening mandates from the FDA, which has maintained its policy of enforcement discretion for the use of FMT for CDI not responding to standard therapy. Here, we examine the evolving risk landscape of FMT.
Date Issued
2021-04-01
Date Acceptance
2020-10-27
Citation
American Journal of Gastroenterology, 2021, 116 (4), pp.647-656
ISSN
0002-9270
Publisher
Lippincott, Williams & Wilkins
Start Page
647
End Page
656
Journal / Book Title
American Journal of Gastroenterology
Volume
116
Issue
4
Copyright Statement
© 2021 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited. This is a non-final version of an article published in final form in The American Journal of Gastroenterology, 116 (4), 647-656, https://doi.org/10.14309/ajg.0000000000001075
Sponsor
Imperial College Healthcare NHS Trust- BRC Funding
Identifier
https://journals.lww.com/ajg/Fulltext/2021/04000/Fecal_Microbiota_Transplantation__The_Evolving.13.aspx
Grant Number
RDA27
Subjects
Gastroenterology & Hepatology
1103 Clinical Sciences
Publication Status
Published
Date Publish Online
2021-02-05