Q: My 78-year-old father developed drug-resistant C. diff and almost died from diarrhea and dehydration. He received a stool transplant from his nephew, and it cleared up the condition quickly. So why is the Food and Drug Administration trying to restrict the use of it?
SALLY P., Richmond, Va.
A: About 80 percent of people in the U.S. who battle chronic diarrhea and other problems caused by a Clostridium difficile bacterial infection are over age 65 and often have been on antibiotics. C. diff can exist naturally in the gut, but taking antibiotics kills off other gut-dwelling bacteria that keep it in check. The result: The bad bacteria flourishes and causes chronic bouts of potentially lethal gastrointestinal distress. We know that fecal-microbiota-transplantation (FMT) transferring someone elses bacteria-rich stool into your digestive tract can cure the infection 90 percent of the time.
But this past February, the FDA decided FMT should be regulated as a biologic drug and doctors needed to apply for an investigational new drug (IND) application before performing the procedure. This triggered a huge outcry from doctors and patients. As a result, the FDA reversed the decision, now allowing FMT to be used to treat C. diff without applying for an IND.
What the FDA had wanted to accomplish was a way to more carefully monitor the procedure. While there are currently guidelines that call for screening of donors and donor stools for parasites, HIV, hepatitis, etc., more study is needed. So anyone considering FMT should make sure the doctor performing the procedure has experience doing it. At least two drug companies are developing capsules of FMTs that can be as easily and safely used as probiotics, but we expect were several years from that.
Mehmet Oz, M.D., is host of The Dr. Oz Show, and Mike Roizen, M.D., is chief medical officer at the Cleveland Clinic Wellness Institute. Distributed by King Features Syndicate.