A group of doctors at Massachusetts General Hospital have published an article in the New England Journal of Medicine that explains what happened in the first death attributed to a fecal transplant. The 73-year-old patient had been participating in a clinical trial involving fecal microbiota transplants, or FMTs, at the hospital when he died. The incident was later attributed to infected stool from a donor that had been stored in a freezer for several months.
The man who died was part of a clinical trial looking at using FMT to rebuild the immune systems of leukemia patients who had received chemotherapy and stem cell transplants. The patient was given the capsules before undergoing a bone marrow transplant. Eight days after his last FMT dose, he began to decline precipitously and was placed on a ventilator. He died two days later from a severe bloodstream infection.
When the researchers investigated the source of the patient’s infection, they discovered that the stool sample used for the FMT contained a type of E. coli bacteria that was resistant to multiple antibiotics. While fecal microbiota transplants remain unapproved by the Food and Drug Administration, the death spurred the agency to issue new safety guidelines for the procedure. The agency also urged researchers to suspend fecal transplants until labs could safely screen for drug-resistant microbes.
The FMT procedure transfers feces from healthy donors to the bowels of sick patients in an effort to restore the community of beneficial bacteria and other organisms in the intestines. It is generally used to treat a deadly bacterial infection known as Clostridium difficile, which kills thousands of Americans annually. Researchers have also been exploring its use for a wide range of conditions, including Alzheimer’s, inflammatory bowel disease, liver disease, autism, obesity and multiple sclerosis.