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Background. There is increasing recognition that fecal transplant (FT) is an effective treatment for recurrent C. difficile infection (CDI). However, donor screening and product preparation can be burdensome. Despite promising efficacy results, safety data are limited. We report on a 60-day interim analysis of the first prospective open-label multi-center safety study of a next generation microbiota restoration therapy that has been standardized and manufactured under controlled conditions.

Methods. Patients with recurrent CDI, defined as at least 3 CDI episodes or at least 2 severe episodes resulting in hospitalization, were enrolled. All patients received treatment with RBX2660 (microbiota suspension) administered via enema. A second treatment was permitted if CDI recurred in< 8 weeks after the first treatment. Follow-up was at 7, 30 and 60 days and 3 and 6 months after the last treatment. The primary objective was …