Two patients fell ill, and one subsequently died, following a fecal microbiome transplant, according to the New York Times. It adds that the US Food and Drug Administration has paused a number of clinical trials involving fecal transplants until the researchers involved can show they screen transplant samples for multi-drug-resistant organisms.
The patients, both of whom were immuno-compromised, received a transplant from the same donor that contained multi-drug-resistant bacteria, the Times says. Other stored samples from that donor were also found to harbor multi-drug resistant Escherichia coli, the Times reports. It says the donor sample was not screened for this type of extended-spectrum beta-lactamase-producing E. coli.
In its safety alert, FDA says fecal microbiome transplant studies need to conduct donor screening for multi-drug resistant organism risk factors and exclude individuals at a high risk of harboring such organisms. Additionally, it says stool should be tested for such organisms and, if positive, be excluded from use.
The Times notes that FDA did not say what type of fecal microbiome transplant — pill or infusion — the patients received or why the patients were immuno-compromised.