Serious infections have occurred in adults who received investigational fecal microbiota transplantation (FMT) containing multidrug-resistant organisms, the FDA recently warned.
One immunocompromised patient died and another was infected after receiving preparations that used the same donor's stool, which contained extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli. The donor stool and resulting FMT preparation used in the two patients were not tested for ESBL-producing gram-negative organisms prior to use. After these two cases, stored preparations of fecal microbiota from the stool donor tested positive for ESBL-producing E. coli identical to the organisms isolated from the two patients.
In response to the cases, the FDA proposed additional safety protections for the investigational use of FMT. The agency recommended screening donors for risk factors for colonization with multidrug-resistant organisms and exclusion of individuals at increased risk of colonization. It's also necessary to test donor stool for multidrug-resistant organisms and exclude stool that tests positive, the FDA said.