Safety and Efficacy of Fecal Microbiota, Live-jslm, in Preventing Recurrent <i>Clostridioides difficile</i> Infection in Participants Who Were Mildly to Moderately Immunocompromised in the Phase 3 PUNCH CD3-OLS Study.

ABSTRACT:

Background

Fecal microbiota, live-jslm (RBL; Rebyota), is the first Food and Drug Administration-approved, single-dose, microbiota-based live biotherapeutic to prevent recurrent Clostridioides difficile infection (rCDI) in adults following standard-of-care antimicrobials. Patients who are immunocompromised are often considered at higher risk for C difficile infection, including recurrence, as compared with those who are immunocompetent. This subgroup analysis of PUNCH CD3-OLS (NCT03931941) evaluated RBL safety and efficacy in participants with rCDI who were considered mildly to moderately immunocompromised.

Methods

Participants with rCDI who had immunocompromising conditions and/or were taking immunosuppressive medications were included. Treatment-emergent adve

SUBMITTER: Alonso CD 

PROVIDER: S-EPMC11961354 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature