According to a story from NBC News, the US Food and Drug Administration (FDA) issued an announcement during the summer detailing a patient death linked to the use of fecal microbiota transplant (FMT) as well as another case in which a patient fell ill after the procedure. We have previously written about this incident as well (you can check that story out here to get up to speed). At the time, doctors and other medical professionals were concerned about the announcement because it lacked in-depth information surrounding the circumstances of the incident. Now, a more recent, detailed report regarding the case has been released.
The report was published in the New England Journal of Medicine. The report comes from doctors associated with the Massachusetts General Hospital, which is where the patients were being treated with FMT as part of clinical trials.
About Fecal Microbiota Transplant (FMT)
Fecal microbiota transplant is a procedure in which fecal material from a healthy donor is implanted into the gut of a patient. It is typically used to treat Cloistridioides difficile infections, but a lot of ongoing research is investigating whether the process has the potential to be useful in treating a much broader swathe of disease and medical conditions. The effectiveness of FMT is rooted in the importance of the gut microbiome, which is the population of many types of bacteria and other microorganisms that live in our digestive system.
Circumstances of Death Revealed
One of the patients received FMT as part of a trial which was testing it in patients with severe liver disease. The goal of the treatment was to improve cognitive function. After this patient’s last dose, drug resistant E. coli was detected in their blood. Heavy antibiotic treatment was able to get rid of it, but the doctors traced the bacteria to the stool sample used in the procedure.
This same sample was used in another patient in another trial that was testing FMT in leukemia. The hope was that FMT would help reboot the immune system after extensive treatment with stem cell transplants and chemotherapy. This patient, in a weakened immune state, soon fell victim to the same strain of E. coli and could not be saved.
The sharing of these details was widely praised by the broader medical community, and highlights the need for safeguards that screen stool samples for these dangerous pathogens before use in a transplant.
