Poop transplant claims one life, prompts FDA warning

Grant Boone
June 17, 2019

Fecal transplants are now administered by collecting stool from healthy donors to reset the gut bacteria in a patient's gastrointestinal (GI) tract.

Unfortunately, one of the patients eventually died.

Fecal transplants are typically used as a treatment for C. difficile, which per CDC stats kills 29,000 Americans yearly, reports NBC News.

The Food and Drug Administration on Thursday published a bulletin warning against possible complications from faecal microbiota transplantation (FMT), which has been rising in popularity for the treatment of C. diff, a debilitating gut infection.

The donor stool used in both patients had not been tested for ESBL-producing gram-negative organisms prior to use, and subsequent testing has showed the stool to be positive for ESBL-producing E coli. Although FMT is not approved by the FDA for any use, the agency plays a critical role in supporting product development while assessing the risks and benefits to patients of unapproved therapies.

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A fecal transplant provides a more favorable combination of microbial species and strains that complements and replaces a microbiome that has become imbalanced.

In response to these adverse outcomes, the FDA announced new standards requiring researchers in clinical trials to demonstrate proper screening procedures for donor stool.

Fecal transplants have been on the rise as a way to treat severe intestinal disorders, specifically an infection caused by bacterium called Clostridium difficile, which can be deadly and tend to occur in confined patients who have been heavily treated with antibiotics. His writing has appeared in numerous Canada's most respected and credible publications, including the Toronto Star, CBC News and on the cover of Smithsonian Magazine.

The agency also listed protections that they consider important for any fecal transplants, including donor screening with questions that address risk factors and testing of the donor stool. Many who have tried a fecal transplant said it improved their symptoms, which can be tempting for those with chronic and debilitating symptoms when many other treatments have failed. In light of the recent patient's death, the FDA said more work needs to be done before it will expand the use of fecal transplants in research and clinical practice. We've become aware of infections with multi-drug resistant organisms after patients received investigational FMT, including one patient death.

The FDA didn't disclose where the stool came from or the organization that provided the transplant. "We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients".

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