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Fecal matter transplant
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== Risk == The [[U.S. Food and Drug Administration]] (FDA) has warned of the possiblity that FMT may cause serious or life threatening infections, including bacterial and viral infections, with at least one fatal infection reported.<ref name="FDA-sar2019">{{Cite web | url=https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse | title = Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms | last = | first = | authorlink = | date = Jun 13, 2019 | website = U.S. Food & Drug Administration|archive-url=|archive-date=|url-status=|access-date=Jun 15, 2019}}</ref><ref name="FDA-covid19-2020">{{Cite web | url=https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-regarding-additional-safety-protections-pertaining | title = Fecal Microbiota for Transplantation: Safety Alert - Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19 | last = | first = | authorlink = | date = Mar 23, 2020 | website = U.S. Food & Drug Administration|archive-url=|archive-date=|url-status=|access-date=Apr 17, 2020}}</ref> === Multi-drug resistant organisms === The FDA reported two cases in immunocompromised adults of bacterial infections with multi-drug resistant organisms (MDROs) that occurred due to use of investigational FMT.<ref name="FDA-sar2019" /> In both cases, the FMT was prepared from stool obtained from the same donor, and the recipients became infected with extended-spectrum beta-lactamase (ESBL)-producing [[Escherichia coli]] (E.coli), which was later found to be present in donor stool.<ref name="FDA-sar2019" /> One of the recipients died.<ref name="FDA-sar2019" /> As a result of these cases, the FDA has determined that donor screening must include questions that address risk factors for MDROs and donor stools must be tested for MDROs.<ref name="FDA-sar2019" /> ===SARS-CoV-2 and COVID-19=== The [[Severe acute respiratory syndrome coronavirus 2|SARS-CoV-2]] RNA and/or virus that causes [[COVID-19]] has been found in stool samples, suggesting it could be transmitted by FMT.<ref name="FDA-sar2019" /> The FDA has stated the risk is unknown and advised donor screening for SARS-CoV-2 and testing donors or donor stools be screened, and informing patients of the potential risk.<ref name="FDA-sar2019" />
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