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Researchers Study Potential Risks of FMT
Fecal microbiota transplantation (FMT) is widely considered safe and effective in treating patients with Clostridioides difficile infection (CDI).
With FMT’s increased use and popularity for CDI treatment, and recent cases of SARS-CoV-2, and rare cases of multidrug resistant organisms (MDRO), Shiga toxin-producing Escherichia coli (STEC), and Enteropathogenic Escherichia coli (EPEC), researchers sought to analyze potential risks of FMT.
“FMT is largely considered a safe procedure although risks described range from mild gastrointestinal symptoms to serious infection. Currently, there is variability in how “FMT” is characterized specifically regarding testing approach, which, in turn, impacts the risk profile,” the authors reported.
The authors analyzed rare cases of MDRO, STEC, and EPEC (which were reported, but not screened, following the US Food and Drug Administration’s (FDA) enforcement discretion policy of treating patients with CDI unresponsive to standard therapy, with FMT.
“From a clinical perspective, appropriate patient selection, standardized and rigorous donor screening, detailed informed consent, and close follow-up are needed to safeguard patient care. However, until there is an approved product enabling patient access, FMT is an essential therapeutic despite its intrinsic testing/manufacturing variability and pragmatic limitations,” the authors concluded.
--Angelique Platas
Reference:
Gupta S, Mullish BH, Allegretti JR. Fecal microbiota transplantation: the evolving risk landscape. Am J Gastroenterol. April 2021 116(4)647-656