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Oversight for Fecal Transplants

Clinicians and researchers are examining the use of fecal transplants to treat a number of diseases that appear to be gut microbiome-related, especially for recurrent Clostridium difficile . A group in Canada has even developed a synthetic stool mix, called RePOOPulate, that they say may be safer and "less icky" than other fecal transplant treatments.

The US Food and Drug Administration has taken an interest in such treatments, MedPage Today's Kristina Fiore writes. The agency says that fecal micriobiota falls under the biologic products aspect of its purview and physicians who plan to treat patients with such transplants need to file Investigational New Drug applications.

FDA, Fiore adds, recently held a two-day hearing and that further information from the agency should be forthcoming.

"The FDA has been clear for some time now that for fecal transplantation ... it is necessary to have an IND for some type of regulation and oversight," the University of Chicago David Rubin tells her. Rubin, who attended the hearing, is studying fecal transplantation in ulcerative colitis patients.