Earlier this year, the U.S. Food and Drug Administration (FDA) issued a warning about the safety of so-called fecal microbiome transplants (FMTs). The announcement came after two patients received a fecal transplant from the same donor and contracted the drug-resistant E. coli. One of the patients recovered from the disease, but the other, a 73-year-old with blood cancer, eventually died.
Fecal microbiome transplantation is a relatively new treatment for patients with intestinal flora imbalances in the digestive system. The presence of tiny organisms in the gut is important for a person’s health, and if the flora is unbalanced, it can cause many problems. Fecal microbiome transplantation is one way to solve it, but there are many risks.
“The FDA is informing healthcare providers and patients about the potential risk of serious or life-threatening infections using fecal microbiome transplant therapy,” the agency explained in a June announcement. The agency is now aware of bacterial infections caused by multi-resistant bacteria (MDRO), which are caused by the use of research FMT to spread MDRO. “
The report on the incident, just published in the New England Journal of Medicine, suggests that some disturbing screening guidelines may have played a role in infection.
After some potential infection risks require a more rigorous screening process for fecal microbiome donors, medical centers have changed the way they validate each sample. Unfortunately, the hospital did not retroactively apply these new screening guidelines, and the old samples stored at the facility were not treated the same way.
In addition, doctors believe that a round of antibiotic treatment for the two patients before the fecal microbiome transplant may actually make either patient more susceptible to E. coli and reduce the patient’s ability to fight infection.