For patients with intestinal problems, there are a limited number of treatments. If the problem is related to a lack of beneficial bacteria or too much toxin-producing bacteria like Clostridium difficile in a patient's gut, researchers and doctors are trying something new — fecal transplants from healthy individuals to people with intestinal problems. The idea, says Scientific American's Maryn McKenna, is for the beneficial bacteria in the donated stool to re-colonize the patient's intestine.
Although there have been success stories, "fecal transplants remain a niche therapy, practiced only by gastroenterologists who work for broad-minded institutions and who have overcome the ick factor," McKenna says. For the procedure to become more common, it has to be studied in clinical trials and, for that to happen, such studies must be granted investigational status by FDA. The problem, McKenna says, is that FDA considers drugs, devices, and biological products to be investigational, and "feces simply do not fit into any of those categories."