On March 23, 2020, FDA issued a warning about the potential risk of transmission of COVID-19 (SARS-CoV-2) virus by Fecal Microbiota Transplant (FMT) products. Fecal microbiota transplant is considered an investigational treatment for resistant Clostridium difficile (C difficile) infection. Recent studies found COVID-19 virus or its ribonucleic acid (RNA) in the stool of infected individuals. These findings suggest that COVID-19 may be transmitted through FMT. However, the risk of transmission via FMT is unknown at this time and information on availability and sensitivity of direct stool testing for COVID-19 is rapidly evolving.
Healthcare providers and patients are being informed by the FDA of the potential risk of transmission of COVID-19 via FMT and subsequent adverse events. The FDA updated the alert on April 9, 2020 with recommending stools donated on or after December, 1, 2019 to have no clinical use until completion of additional protections. These include donor screening and testing for suspected or confirmed COVID-19 or SARS-CoV-2 cases, testing of stool for SARS-CoV-2 virus or RNA, and conveying to the recipient during the informed consent process, asymptomatic stool donors may be infected with SARS-CoV-2.
Report suspected adverse events associated with FMT to the FDA MedWatch Program: http://www.fda.gov/medwatch.
More information is available at the following links: