Faecal microbiota transplant (FMT) involves the medically supervised and coordinated transplant of feacal organisms from one human to another for therapeutic purposes. This medical procedure is still in its early days, and first reports of serious adverse effects have now emerged. FMT is used to treat (C. difficile) infection in patients who have not responded to standard therapies. The FDA requires that a physician should obtain adequate consent for the use of FMT from the patient or his or her legally authorized representative. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks.
The FDA has become aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to transmission of a MDRO from use of investigational faecal microbiota for transplantation (FMT) – these two patients (One of whom died) were immunocompromised adults who received investigational FMT and developed invasive infections caused by extended-spectrum beta-lactamase (ESBL) producing Escherichia coli (E.coli). The faecal materials transplanted were prepared from stool obtained from the same donor (who has not tested or screened).