OpenBiome -Nation’s 1st Human Stool Bank

From NY Times:

An excerpt:
Around noon on a recent Friday, Donor Five, a healthy 31-year-old, walked across M.I.T.’s frigid, wind-swept campus to a third-floor restroom to make a contribution to public health.

Less than two hours later, a technician blended the donor’s stool into preparations that looked like chocolate milk. The material was separated and stored in freezers at an M.I.T. microbiology lab, awaiting shipment to hospitals around the country. Each container was carefully labeled: Fecal Microbiota Preparation.

Nearly a year ago, Mark Smith, a 27-year-old doctoral candidate, and three colleagues launched OpenBiome, the nation’s first human stool bank. Its mission: to provide doctors with safe, inexpensive fecal material from screened donors to treat patients with Clostridium difficile, a gastrointestinal infection that kills at least 14,000 Americans a year.

“People are dying, and it’s crazy because we know what the solution is,” Mr. Smith said. “People are doing fecal transplants in their basements and may not be doing any of the right screening or sterile preparation. We need an intermediate solution until there are commercial products on the market.”…

The bacteria are increasingly resistant to conventional treatments. But researchers have discovered an alternative: A donor’s stool can be transplanted in the intestine or colon of a sick patient via an enema, colonoscopy or nasogastric tube. The healthy bacteria fight off C. diff and re-establish a normal community in the gut.

A study published last year in The New England Journal of Medicine found that fecal transplants were nearly twice as effective as antibiotics in treating patients with recurring C. difficile.

But where to get healthy donor stool? For doctors, it’s a tedious, time-consuming process, and some patients turn awkwardly to relatives or friends. Since September, OpenBiome has delivered more than 135 frozen, ready-to-use preparations to 13 hospitals. The nonprofit project fields dozens of requests from doctors, hospitals and patients every week. (The preparations are not sent directly to patients.) 

Carol Capps, 75, a retired nurse in Clemmons, N.C., had been in and out of hospitals for months with a C. diff infection that was not going away despite multiple courses of antibiotics. After a recurrence, her doctor suggested OpenBiome, and she received a fecal transplant. By that afternoon, Ms. Capps said, she felt like a new person and has been healthy since…

Because of the legal ambiguity, some researchers are not preparing fecal microbiota for sale (usually at cost) …

At the same time, Mr. Smith and Eric J. Alm, an M.I.T. microbiologist and adviser to OpenBiome, said the F.D.A.’s classification of fecal transplants as drugs hinders research into their possible uses to treat inflammatory bowel diseases and obesity.

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