SCIENCE
05/30/2013 07:57 am ET Updated May 31, 2013

Fecal Transplant Crackdown: FDA Moves To Regulate Infection-Fighting 'Stool' Treatment

The FDA is cracking down -- but not on a dangerous drug or nutritional supplement. The agency has issued strict new guidelines regarding poop -- or, more specifically, the use of fecal transplants to treat severe and potentially lethal bacterial infections.

Known formally as fecal microbiota for transplantation (FMT) -- and less formally as fecal bacteriotherapy or simply stool transplants -- the transplants involve taking bacteria-laden feces from a healthy person and inserting it (via colonoscope, nasogastric tube, or enema) into the colon of an individual infected with the bacterium Clostridium difficile.

C. difficile can cause severe, debilitating diarrhea that often can't be controlled even with powerful antibiotics. Yet fecal transplants have proven highly effective at curbing C. difficile infection, with one recent study showing them to be more effective than the powerful antibiotic Vancomycin for the treatment of recurrent infections (by helping to recolonize the colon with healthy bacteria).

But in a recent letter to the American Gastroenterological Association, the agency indicated that doctors who wish to treat a patient with a fecal transplant must first file a so-called "investigational new drug application" (NDA), according to a blog published on Wired.com on May 19. As the blog explained:

This requires a lot of advance paperwork, 30 days of consideration, and does not return not a guaranteed yes [sic]. For the transplants, which have been performed informally but carefully by a growing number of physicians as a treatment (and often cure) for devastating C. difficile infection, it may improve safety, but it can't help but impose obstacles and delay.

If that sounds like a needless roadblock, the agency has an explanation:

"It is FDA's duty to ensure that a drug is safe, effective and does not expose a patient to unreasonable risks," FDA spokesperson Curtis Allen told The Verge in an email.

But might the FDA's decision be putting needless obstacles between patients and effective treatment?

Last August, Rhiannon Maher, then a 20-year-old college student, was diagnosed with C. difficile after experiencing diarrhea, vomiting, and high fevers so severe that she had to drop out of college and quit her job, according to The Verge. The antibiotics her doctors prescribed helped at first, but the infection kept coming back.

"I was in a lot of pain," Maher told The Huffington Post in an email. "I couldn't eat. I was dehydrated, couldn't stand up without getting dizzy and my doctor wanted to put me back in the hospital for the ninth time so I could be on IV fluids and more antibiotics. My mother thought I was dying."

Maher's mother, Paula Peters, begged doctors to give her daughter a fecal transplant, but doctors demurred on account of the new FDA policy, according to The Verge. So her mother followed online video tutorials and transplanted some of her own stool into her daughter.

"I noticed improvement right away in my energy level, less frequency going to the bathroom," Maher told The Huffington Post. "My appetite hasn't quite come back yet but my colon will take some time to heal because of the damage done by the C. diff."

The fecal transplants haven't been a "magic bullet," Maher said in the email. But, she said, "I can eat and go to work and function like a normal person, which is all I wanted to do."

The Centers for Disease Control and Prevention estimates that diarrhea resulting from C. difficile infections kills 14,000 Americans each year.

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