The Food and Drug Administration (FDA) issued a safety alert this week informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT) and that FDA has determined that additional safety protections are needed.

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Several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals. This information suggests that SARS-CoV-2 may be transmitted by FMT, although the risk of such transmission is unknown. At this time, testing nasopharyngeal specimens from stool donors for SARS-CoV-2 may not be widely available. Furthermore, there is limited information on the availability and sensitivity of direct testing of stool for SARS-CoV-2.

Due to the potential for serious adverse events to occur, FDA has determined that the following protections are needed for any use of FMT that is found to be necessary for clinical care if it involves stool donated after December 1, 2019:
  • Donor screening with questions directed at identifying donors who may be currently or recently infected with SARS-CoV-2.
  • Testing donors and/or donor stool for SARS-CoV-2, as feasible.
  • Development of criteria for exclusion of donors and donor stool based on screening and testing.
  • Informed consent that includes information about the potential for transmission of SARS-CoV-2 via FMT, including FMT prepared from stool from donors who are asymptomatic for COVID-19.