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FDA Approves First Fecal Transplant Pill

SER-109 is the second human feces-derived treatment to be approved by the FDA. The first was Rebyota in December of 2022.

Nejm
NEJM

C. diff is a bacterial infection that can cause severe diarrhea and inflammation of the colon, and it often recurs even after treatment with antibiotics. According to a recent LIFE-SCIENCE article, the FDA has approved the first-ever pill made from human feces for the treatment of recurrent Clostridioides difficile (C. diff) infection. The pill, called "SER-109," contains spores from multiple strains of bacteria found in healthy feces that can help restore the gut microbiome and fight off C. diff infections.

SER-109 is designed to help prevent recurrent C. diff infections by restoring a healthy balance of gut bacteria. In clinical trials, the pill was found to be highly effective, with a success rate of 88.9% compared to just 29.4% in the placebo group. The approval of SER-109 is a significant step forward in the treatment of recurrent C. diff infections, and it could potentially lead to the development of other microbiome-based therapies for a range of conditions.

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