Flora Medicine’s Response to the FDA Alert Regarding Fecal Transplant

On June 13, 2019 the Food and Drug Administration (FDA) reported that two immunocompromised individuals contracted a multi-drug resistant organism (MDRO) from the same donor after seeking fecal microbiota transplant (FMT) through a clinical trial. One of these individuals, subsequently died. The organism was extended-spectrum beta-lactamase (ESBL) producing Escherichia coli (E.coli).