Background: Microbiota-based treatments have shown promise to reduce recurrence for recurrent Clostridioides difficile infections (rCDI), but consistent and reliable safety data are needed to support regulatory approvals and broaden patient access. Here we provide cumulative safety data from 5 prospective clinical studies evaluating RBX2660—a standardized, microbiota-based investigational live biotherapeutic—for reducing rCDI. Methods: This analysis included [...]

Background: Recurrent Clostridioides difficile infection (rCDI) is an urgent public health threat. RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic that has been evaluated in 5 prospective clinical trials. Eligibility criteria in clinical trials are often narrowly defined, excluding broader patient populations. Herein, we report a retrospective analysis of safety and efficacy of RBX2660 [...]