Swapping Germs: Should Fecal Transplants Become Routine for Debilitating Diarrhea?

A potentially beneficial but unusual treatment for serious intestinal ailments may fall victim to regulatory difficulties

Proponents have come up with work-arounds for those possible barriers. Khoruts no longer uses related donors—which requires finding a different individual for every case—but instead has recruited a cadre of “universal donors” from among local health care workers. (He has seen no change in how often the transplants “take.”) Last year Michael Silverman of the University of Toronto boldly proposed a yet more streamlined solution: having patients perform the transplants at home with a drugstore enema kit. A drawback, he cautioned in Clinical Gastroenterology and Hepatology, is that too much of the stool solution might leak out for the transplant to take. Nevertheless, seven patients with recurrent C. diff have safely performed the home version, he wrote, with a 100 percent recovery rate.

Next Steps
Even without large-scale rigorous investigations of fecal transplants, the medical community appears to be coming around to the practice. The Journal of Clinical Gastroenterology editorialized in September 2010 that “it is clear from all of these reports that fecal bacteriotherapy using donor stool has arrived as a successful therapy.” Albert Einstein’s Brandt recently suggested in the same journal that fecal transplants should be the first treatment tried for serious C. diff infection rather than a last resort. Increasing research interest in the influence of gut flora on the rest of the body—and on conditions as varied as obesity, anxiety and depression—will likely bring pressure for transplants to be adopted more widely.

Currently three clinical trials of fecal transplants have begun in Canada. In the U.S., however, the research logjam persists. An FDA spokesperson said in an interview that there is no way to determine how the agency might rule on an investigational application until the application is brought. That tosses the initiative back to Kelly and her collaborators, who include Khoruts and Brandt. They hope to file with the FDA before much longer, but Kelly admits to being apprehensive over the possible outcome.

“We hope they will not ask things that we cannot answer,” she says. Medical centers need to be able to study the procedure, Kelly argues, “because people are trying it on their own.”

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