Although FMT is not approved by the FDA for any use, the agency plays a critical role in supporting product development while assessing the risks and benefits to patients of unapproved therapies. This problem occurs each year, and two million people from the United States are getting an antibiotic-resistant infection.
A fecal transplant provides a more favorable combination of microbial species and strains that complements and replaces a microbiome that has become imbalanced. The goal is to introduce good bacteria in the body. It involves taking fecal matter from a healthy donor and delivering it into a patient's colon, either directly, through an enema or other infusion of stool, or with the use of "poop pills", capsules containing fecal matter that patients take by mouth.
But determining who a good donor is by no means as simple as asking around to friends and family about who has regular bowel movements.
"While we support this area of scientific discovery, it's important to note that FMT does not come without risk", Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. Subsequent testing of stored samples from this donor confirmed the presence of ESBL-producing E. coli. It's been primarily used to treat serious infections of antibiotic-resistant forms of the Clostridium difficile (C. difficile) bacterium.
The experimental procedure has shown promise for patients whose digestive systems have been thrown into disorder by the use of antibiotics.
Also, when fecal microbiota transplants are used, doctors need to have adequate informed consent from the patient, the FDA said. Interest in fecal transplants has also extended into more unexpected realms, like autism. In this context, fecal transfer has emerged as promising approach to restoring a healthy gut microbiome in order to treat diseases of the gut.
In light of the adverse events, the FDA said yesterday it recommends that donor screening questions specifically "address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs". "We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients". We've become aware of infections with multi-drug resistant organisms after patients received investigational FMT, including one patient death.