Policy: How to regulate faecal transplants
Today in Nature, a new comment by Mark B. Smith, Colleen Kelly, and Eric J. Alm makes the case that stool used in medical practice should be regulated like tissue or blood, and not like a drug, as current regulations dictate. The piece highlights the role for stool banks like OpenBiome in facilitating safe access to material, to avoid circumstances in which patients, with no other alternatives, try to perform fecal transplants themselves. Here’s an excerpt:
“[The first randomized controlled trial investigating the medical use of human feces] was stopped ahead of schedule because the faecal slurry was more than twice as effective in resolving symptoms as antibiotics alone1. Non-randomized studies, with outcomes collected from hundreds of people suffering from recurrent C. difficile infections and treated with similar procedures, have had typical success rates of around 90% (ref. 2).
First described3 in the scientific literature in 1958, faecal microbiota transplantation (FMT), delivers processed stool from a healthy individual to the gut of a sick person through enema, colonoscopy or other means. The goal is to displace pathogenic microbes from the intestine by re-establishing a healthy microbial community. Interest has surged in the past five years (see ‘Stool treatment’). At the same time, new regulatory barriers have made FMT more difficult to study or practice.”
Mark is a co-founder of OpenBiome and PhD candidate in microbiology at MIT, Dr. Colleen Kelly is a gastroenterologist and clinical assistant professor of medicine at the Alpert Medical School at Brown University, and Dr. Eric Alm is an associate professor of biological engineering at MIT and OpenBiome team member.
Read the full piece here.