FDA approves 1st fecal transplant therapy for C. diff

The FDA approved the first fecal transplant therapy, Rebyota, for people with ongoing Clostridioides difficile, ABC News reported Nov. 30.

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Rebyota is a therapy manufactured by stool donations that are screened for dozens of infections and viruses. It is delivered via the rectum as a one-time procedure. Two studies showed 70 percent of people who received Rebyota overcame C. diff after eight weeks, compared to 58 percent of patients who received a placebo.

Fecal transplants have been shown to help recipients fight C. diff bacteria, and the treatment has grown more common as many patients no longer respond to antibiotics. However, regulating the fecal matter used has been a “regulatory headache for the FDA,” according to the report.

The treatment is only for patients who have already taken a course of antibiotics for recurrent infection.

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