Researchers who have been reporting success with the use of fecal transplant to treat resistant C. difficile are likely to need an OK from the the FDA to continue that treatment.
The reason the FDA is stepping into the "poop" involves the way in which the agency interprets existing regulations that cover biologic drugs. Fecal microbiota, it said, meets the definition of a biologic product and such products require an IND (Investigational New Drug (IND) Application) before they are tested in humans.
"Fecal transplants .... between the healthy to the sick already occur in order to combat serious gut infections. They are not considered a way out or alternative therapy and can treat irritable bowel syndrome, colitis and constipation. There are some doctors who've found a more palatable way to administer the same bacteria, via a "Russian-doll" of a tablet containing bacteria gathered from healthy human feces. Most commonly the problem is a preponderance of the bacteria Clostridium difficile or C.diff ..... According to the CDC C.diff infections can kill 14,000 people in the United States each year. They do not always respond to antibiotics and in some cases may occur after antibiotic bombardment has killed off harmless bacteria within the gut in the course of other, routine treatment."
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