A Standardized Fecal Microbiota Preparation for Recurrent C. difficile Infection

Transplantation of a fecal microbiota preparation (FMP) is a highly effective therapy for recurrent Clostridium difficile infection (CDI). However, its use is limited by ambiguous regulations and the lack of a standardized product or a common method of administration.

Now, investigators have conducted an industry-funded, multicenter, phase II study to assess the safety and efficacy of a commercially prepared, standardized FMP given by enema to 34 patients with recurrent CDI. The preparation was obtained from four healthy individuals screened for systemic and gastrointestinal pathogens. Each dose consisted of 50 g of stool in 150 mL of saline with polyethylene glycol and contained ≥10⁷ live organisms/mL of frozen suspension in a ready-to-use …