By Deborah Cho
Last summer, the FDA reversed its previous decision that required researchers to file INDs for fecal transplants to treat Clostridium difficile. This decision came without much official explanation as to the reasoning behind the reversal, but can be understood as a result of the unusually high success rates of fecal transplants in treating the deadly infection and the impracticality of applying IND requirements to the procedure. As the FDA guidance notes, however, the agency’s “exercise of discretion regarding the IND requirements” affects only the use of fecal transplant to treat C. difficile and does not apply to the treatment of other diseases or conditions.
Despite the peculiarity of this type of treatment, researchers and patients alike seem to have embraced it for its ability to cure more than just life-threatening infections that have few other viable options. In fact, a physician in Seattle studied the effects of fecal transplants on inflammatory bowel disease. And, as it goes with many drugs, there even seem to be clinics claiming to use fecal transplants to treat weight loss.