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Introduction <p>The safety and efficacy of microbiota-based products in patients with irritable bowel syndrome (IBS) and recurrent <i>Clostridioides difficile</i> infection (rCDI) has not been studied. Fecal microbiota, live-jslm (RBL; REBYOTA<sup>®</sup>) is an FDA-approved, single-dose, microbiota-based product to prevent rCDI in adults following standard-of-care (SOC) antibiotic treatment. This was an exploratory subgroup analysis of PUNCH CD3-OLS, a phase 3, open-label, prospective study conducted in the United States (US) and Canada, to evaluate the safety and efficacy of RBL in participants with documented rCDI and concurrent IBS.</p> Methods <p>Participants aged&#xa0;≥&#xa0;18&#xa0;years with a diagnosis of rCDI and who completed SOC antibiotic treatment were enrolled in this study. The primary endpoint of PUNCH CD3-OLS was the number of participants with RBL- or administration-related treatment-emergent adverse events (TEAEs). Secondary endpoints included treatment success at 8&#xa0;weeks and sustained clinical response at 6&#xa0;months. In this subgroup analysis, ongoing IBS was confirmed based on medical record documentation at the time of RBL administration.</p> Results <p>Among the 697 RBL recipients, 90 had comorbid IBS. After RBL administration, 52 participants with IBS (57.8%) and 278 participants without IBS (45.8%) experienced TEAEs through 8&#xa0;weeks. Most TEAEs were mild (22.2% with IBS, 20.1% without IBS) or moderate (26.7% with IBS, 18.8% without IBS). Serious TEAEs were reported by 1 participant with IBS (pneumonia reported to be unrelated to RBL) and 26 participants without IBS [most of which were related to preexisting conditions (3.1%)]. Among all participants, 68.9% with IBS and 75.6% without IBS had absence of CDI diarrhea through 8&#xa0;weeks after RBL administration. Of the participants with treatment success, 82.3% with IBS and 92.2% without IBS had sustained clinical response through 6&#xa0;months.</p> Conclusion <p>RBL is a safe and efficacious option to prevent CDI recurrence in patients with concurrent IBS.</p> <p><b>Trial registration:</b> ClinicalTrials.gov identifier, NCT03931941.</p>

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Safety and Efficacy of Fecal Microbiota, Live-jslm to Prevent Recurrent Clostridioides difficile Infection in Participants With Irritable Bowel Syndrome

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月10日

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  • Olga C. Aroniadis,
  • Beth Guthmueller,
  • Kaitlin Dehlin,
  • Shivam Srivastava,
  • Paul Feuerstadt,
  • Anthony Lembo,
  • Horst C. Weber

摘要

Introduction

The safety and efficacy of microbiota-based products in patients with irritable bowel syndrome (IBS) and recurrent Clostridioides difficile infection (rCDI) has not been studied. Fecal microbiota, live-jslm (RBL; REBYOTA®) is an FDA-approved, single-dose, microbiota-based product to prevent rCDI in adults following standard-of-care (SOC) antibiotic treatment. This was an exploratory subgroup analysis of PUNCH CD3-OLS, a phase 3, open-label, prospective study conducted in the United States (US) and Canada, to evaluate the safety and efficacy of RBL in participants with documented rCDI and concurrent IBS.

Methods

Participants aged ≥ 18 years with a diagnosis of rCDI and who completed SOC antibiotic treatment were enrolled in this study. The primary endpoint of PUNCH CD3-OLS was the number of participants with RBL- or administration-related treatment-emergent adverse events (TEAEs). Secondary endpoints included treatment success at 8 weeks and sustained clinical response at 6 months. In this subgroup analysis, ongoing IBS was confirmed based on medical record documentation at the time of RBL administration.

Results

Among the 697 RBL recipients, 90 had comorbid IBS. After RBL administration, 52 participants with IBS (57.8%) and 278 participants without IBS (45.8%) experienced TEAEs through 8 weeks. Most TEAEs were mild (22.2% with IBS, 20.1% without IBS) or moderate (26.7% with IBS, 18.8% without IBS). Serious TEAEs were reported by 1 participant with IBS (pneumonia reported to be unrelated to RBL) and 26 participants without IBS [most of which were related to preexisting conditions (3.1%)]. Among all participants, 68.9% with IBS and 75.6% without IBS had absence of CDI diarrhea through 8 weeks after RBL administration. Of the participants with treatment success, 82.3% with IBS and 92.2% without IBS had sustained clinical response through 6 months.

Conclusion

RBL is a safe and efficacious option to prevent CDI recurrence in patients with concurrent IBS.

Trial registration: ClinicalTrials.gov identifier, NCT03931941.