The US FDA is warning healthcare providers the use of fecal microbiota for transplant can lead to serious or life threatening infections if not screened properly after two patients with weakened immune systems who underwent FMT from the same donor developed serious infections, one of which has died. The FDA is halting a number of clinical trials until researchers involved can prove proper testing procedures are in place to screen for dangerous organisms.
According to the US FDA the donor stool had not been tested for extended-spectrum beta-lactamase ESBL- producing E.coli prior to the transplant procedure. After the illness and death occurred a stored preparation of the donor stool was tested and it was found to be positive for the identical strain of drug resistant bacteria found within the two transplant recipients.
In the US FDA statement it was not specified why the patients had received the fecal transplants, but this procedure is commonly used to treat bacterial infections called C. difficile, which can be very difficult to treat, additionally fecal transplants can help to treat other severe intestinal disorders.
The Centers for Disease Control and Prevention estimates are that Clostridium difficile bacterial infections kill 29,000 Americans and make another 450,000 sick each year within the USA alone. Treatment for this bacterial infection involves obtaining stool from a healthy donor, and then transplanting a processed version of it into the patient. The healthy stool will contain a collection of healthy microbiota which should repopulate the colon of the transplant recipient and essentially crowd out the infectious bad bacteria.
