FDA Is Warning Against Fecal Transplants After Person Dies From E. Coli Infection

Though it may sound gross, the benefits of a fecal transplant—taking the feces of one person and introducing it into the gastrointestinal tract of another—are promising for those suffering from a Clostridioides difficile infection. The tenacious infections are often the result of sustained antibiotic use, which can kill the patient's "good" gut bacteria and allow C. difficile to proliferate. As the theory goes, the “good” bacteria in feces transplanted from a healthy person may restore the infected person's microbiome and alleviate symptoms like life-threatening diarrhea.

The treatment, which is not FDA-approved, is risky. The FDA has announced that two people involved in a clinical trial recently received fecal transplants that contained drug-resistant bacteria, with one of them dying as a result.

According to The New York Times, the FDA did not offer details of either case, relating only that both patients were immunocompromised, which is one of the contraindications of receiving the transplant. The stool they received was believed to contain antibiotic-resistant E. coli bacteria.

As a result, the FDA is suspending a number of fecal transplant clinical trials until it can be determined how stool is being tested for contamination with potentially deadly bacteria and why the E. coli was not detected. The stool that infected both patients came from the same donor.

Fecal transplants are considered an experimental treatment for C. difficile infection when first-line treatment like antibiotics are ineffective. The fecal transplant is usually introduced to the digestive tract via pills or an infusion.