The FDA Wants To Make It Harder To Buy And Sell Poop

Gastroenterologist Colleen Kelly performed her first poop transplant eight years ago, on a young woman with a life-threatening gut infection who had run out of options. The bacterium Clostridium difficile had invaded the woman’s gut, bringing her constant diarrhea and pain, and antibiotics weren’t working.

Kelly’s patient persuaded her to try a fecal transplant, in which poop from a healthy person is put into a sick person’s colon in the hope of resetting the mix of microbes there. At the time, it was considered a fringe therapy, but had seemed to cure many patients with C. diffinfections, even though no one quite understood why.

The patient’s boyfriend provided fresh stool, and Kelly introduced half a cup of it into her patient via a colonoscopy. To Kelly’s surprise, it worked — by the next day, the woman’s symptoms began to wane.

Kelly, an assistant professor of medicine at Brown University, has since performed some 300 fecal transplants for C. diff infections. These days, she usually buys healthy stool samples from OpenBiome, a nonprofit “stool bank” in Somerville, Massachusetts that launched in 2013. “It’s really unlike any therapy to date,” she told BuzzFeed News.

So this spring, when the FDA announced that it intended to tighten its rules on the procedure, known as fecal microbiota transplantation (FMT), making it harder for doctors to buy stool from banks, Kelly was among the commenters who wrote back, opposing the proposal.

The new rule could limit FMT to large hospitals, meaning that many fewer patients would have access to it, Kelly and a group of colleagues from the American Gastroenterological Association wrote. “Further, it may inadvertently encourage patients to perform ‘do-it-yourself’ FMT without medical supervision, using FMT material that has not been properly screened.”

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