The faecal microbiota transplant (FMT) may transmit multidrug-resistant organisms, leading to serious life-threatening infections, according to the US Food and Drug Administration (FDA).
Two immunocompromised adults who received FMT was reported to develop invasive bacterial infections caused by extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli, according to a safety communication issued by the agency.
One of the patients wasreported to have died.
The FMT used in these two individuals were prepared from stool obtained from the same donor.
However the FDA noted that the donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use.
After these infections occurred, stored preparations of FMT from this stool donor was found to be positive for ESBL-producing E coli, which was identical to the organisms isolated from the two patients.
The FDA advises FMT donors to be screened with questions that specifically address risk factors for colonization with multidrug-resistant organisms (MDROs) and the individuals found at higher risk should thus be excluded.
The FDA also instructs that donor stool be tested for multi-drug resiistant organisms (MDROs), and that stool that tests positive for MDROs be excluded.