Before few months, two patients had gained fecal microbiota transplants (FMTs). It is a treatment that includes poop transfer, often opted to treat people with a severe intestinal infection. At the time of transplant, both patients had contracted E. coli, a strain resistant to antibiotics. Later in June 2019, the U.S. FDA had announced the death of one patient, and another felt ill due to the transplant. The incident had pushed the agency to fix new safety measures for the approach. But the notification which offered minute details on the two cases left doctors calling for more information. Now the latest report from the New England Journal of Medicines has filled in the blanks.
A group of researchers from Massachusetts General Hospital has detailed the mistakes that had resulted in the death of one patient. Reportedly, the patient had cancer and underwent a fecal transplant as a part of experimental testing. Both patients who grained a fecal implant included an infected fecal matter. Notably, stool from a donor seemed to have strains of E. coli, which is resistant to various antibiotics. The FMT-related death had shaken the emerging sector of fecal transplants.
Dr. Elizabeth L. Hohmann is the leading author of the study who specializes in infectious disease and manages fecal implant trials at Mass General. Dr. Elizabeth has expressed regrets for her lab’s inadequacy to test stool from a donor that had been kept at freezer storage for many months. FMT consists of collecting poop sample from a healthy person and implanting it into an ill person. The aim is to repopulate the gut microbiome with good bacteria in a sick person. The transplants are available in two alternatives, either orally, through capsules of frozen stools or rectally through a colonoscopy. For now, the FMT therapy has not gained approval from the FDA. Still, they are beneficial for curing drug-resistant infections like C. difficile.
In the report, published in NEJM, researchers have stated that they had tested stool for various infections and harmful bacteria. At the time, they had found traces of salmonella, listeria, MRSA, and giardia. But traces of E. coli were absent. The scientists have found that both men had opted for FMT capsules from the same donor. Even more, an additional 22 patients had gained FMT treatment from the person. The researchers were able to analyze 12 people out of those 22 patients for the strain of E. coli.
As a result, five people have tested positive for the drug-resistant bacteria. But they have not revealed any symptoms of infection. Dr. Elizabeth says there is a probability that the two men’s had severe diseases along with a weak immune system. Thus the conditions had contributed to infections in the two. In the end, the cases have proved that there is a need for clear instructions and regulation policies.