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. diff infections, 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.”

Other doctors also chimed in, stressing that patient safety was at stake.

“If the FDA makes it prohibitively difficult for clinicians to work with stool banks, I believe this will actually make the procedure less safe, and of course, less accessible,” wrote Sarah McGill, a gastroenterologist at the University of North Carolina Medical School who has performed about 30 fecal transplants on C. diff patients in the last two years. Her freezer at work, she told BuzzFeed News, is full of poop samples bought from OpenBiome for $385 a pop.

Poop wasn’t on the FDA’s radar until about 2013, when a landmark study showed that a fecal transplant offered relief in 94% of extreme C. diff. cases. As more gastro docs started doing the procedure — not only for C. diff. infections, but Crohn’s disease and irritable bowel syndrome — OpenBiome arrived, suddenly offering a ready, frozen solution to clinics hunting for healthy donors.

In May 2013, citing concerns about safety and a lack of research, the FDA ruled that it would regulate poop (and the bacteria in it) not as a natural substance from the body, like blood or skin, but rather like a pharmaceutical drug, requiring rigorous safety testing before clinical use. After an uproar from gastroenterologists, the FDA granted an exemption to the new rule: Doctors could continue transplanting donated poop for extreme C. diff. infections.



But now the rules are changing again. The FDA’s new proposal would require that even for C. diff. treatments, doctors submit extensive paperwork for each patient needing a sample from a stool bank — treating the sample as an “investigational new drug.” (This rule would apply only to poop from stool banks, on the grounds that a tainted sample there could affect many others. But the additional red tape would not apply to C. diff. patients who get poop from a friend or relative, or from small stool collections stored in hospitals.)