Safety of fecal microbiota, live-jslm (REBYOTA^™) in individuals with recurrent Clostridioides difficile infection: data from five prospective clinical trials.

ABSTRACT:

Background

Microbiota-based treatments reduce the incidence of recurrent Clostridioides difficile infections (rCDIs), but prospectively collected safety data needed to broaden patient access and protect public health have been limited.

Objectives

We provide cumulative safety data from five prospective clinical trials evaluating fecal microbiota, live-jslm (RBL) - the first microbiota-based live biotherapeutic product approved by the US Food and Drug Administration - for preventing rCDI in adults.

Design

Integrated safety analysis includes three phase II trials (PUNCH CD, PUNCH CD2, PUNCH Open-Label) and two phase III trials (PUNCH CD3, PUNCH CD3-OLS) of RBL.

Methods

Trial participants were at least 18 years of age with documented rCDI who completed stand

SUBMITTER: Lee C 

PROVIDER: S-EPMC10272687 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature