Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA^®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection.

ABSTRACT:

Background

Fecal microbiota, live-jslm (RBL; REBYOTA^®), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing Clostridioides difficile infection (CDI) recurrence. Alternative routes of administration are of clinical interest.

Objectives

Evaluate the safety and efficacy of RBL administration via colonoscopy.

Design

Retrospective analysis of electronic medical records of participants administered RBL via colonoscopy under FDA enforcement discretion.

Methods

The number of participants with treatment and/or procedure-emergent adverse events (TEAEs) was evaluated. Treatment success and sustained clinical response, defined as the absence

SUBMITTER: Knapple WL 

PROVIDER: S-EPMC10962041 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature