Treatment efficacy of fecal microbiota-based live biotherapeutics (RBX2660) for the prevention of recurring Clostridioides difficile infection

Published:December 28, 2022DOI:


      • C. difficile infections (CDI) are potentially deadly and serious infections.
      • Around 35% of CDI cases recur despite antibiotic treatment.
      • This meta-analysis pooled 580 participants across 6 trials.
      • Odds ratio of 1.82 (95% CI = 1.37–2.41) was reported favoring fecal microbiota use.
      • In-treatment group efficacy was 72% (95% CI = 68–76%).


      CDI (Clostridioides Difficile Infection), CI (Confidence Interval), DF (Degrees of Freedom), FDA (Food and Drug Administration)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to European Journal of Internal Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


      1. FDA. November 30, 2022 Summary Basis for Regulatory Action - REBYOTA. 2022. Available from:∼:text=The%20requested%20indication%20for%20REBYOTA,combination%20product%20for%20rectal%20administration. Accessed December 10, 2022.

        • Orenstein R
        • Dubberke E
        • Hardi R
        • Ray A
        • Mullane K
        • Pardi DS
        • et al.
        Safety and durability of RBX2660 (microbiota suspension) for recurrent Clostridium difficile infection: results of the PUNCH CD study.
        Clin Infect Dis. 2016; 62: 596-602
        • Khanna S
        • Assi M
        • Lee C
        • Yoho D
        • Louie T
        • Knapple W
        • et al.
        Efficacy and safety of RBX2660 in PUNCH CD3, a Phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrent Clostridioides difficile infection.
        Drugs. 2022; 82: 1527-1538
        • Orenstein R
        • Dubberke ER
        • Khanna S
        • Lee CH
        • Yoho D
        • Johnson S
        • et al.
        Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial.
        BMC Infect Dis. 2022; 22: 1-13
        • Kwak S
        • Choi J
        • Hink T
        • Reske KA
        • Blount K
        • Jones C
        • et al.
        Impact of investigational microbiota therapeutic RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial.
        Microbiome. 2020; 8: 1-16
        • Blount KF
        • Shannon WD
        • Deych E
        • Jones C.
        Restoration of bacterial microbiome composition and diversity among treatment responders in a phase 2 trial of RBX2660: an investigational microbiome restoration therapeutic.
        Open forum Infect Dis. 2019; 6 (Oxford University Press US): ofz095
        • Dubberke ER
        • Lee CH
        • Orenstein R
        • Khanna S
        • Hecht G
        • Gerding DN.
        Results from a randomized, placebo-controlled clinical trial of a RBX2660—a microbiota-based drug for the prevention of recurrent Clostridium difficile infection.
        Clin Infect Dis. 2018; 67: 1198-1204
        • Langdon A
        • Schwartz DJ
        • Bulow C
        • Sun X
        • Hink T
        • Reske KA
        • et al.
        Microbiota restoration reduces antibiotic-resistant bacteria gut colonization in patients with recurrent Clostridioides difficile infection from the open-label PUNCH CD study.
        Genome Med. 2021; 13: 1-18