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用于预防肠易激综合征患者复发性艰难梭菌感染的活粪微生物群-jslm的安全性和有效性。

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

作者信息

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

机构信息

Division of Gastroenterology and Hepatology, Renaissance School of Medicine, Stony Brook University, 101 Nicolls Road HSC T17-060, Stony Brook, NY, 11794-8173, USA.

Ferring Pharmaceuticals, Inc., 100 Interpace Parkway, Parsippany, NJ, 07054, USA.

出版信息

Infect Dis Ther. 2025 Aug 10. doi: 10.1007/s40121-025-01208-0.

DOI:10.1007/s40121-025-01208-0

PMID:40784972

Abstract

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.

摘要

引言

基于微生物群的产品在肠易激综合征（IBS）和复发性艰难梭菌感染（rCDI）患者中的安全性和有效性尚未得到研究。粪便微生物群产品live-jslm（RBL；REBYOTA）是一种经美国食品药品监督管理局（FDA）批准的单剂量、基于微生物群的产品，用于在接受标准治疗（SOC）抗生素治疗后的成年人中预防rCDI。这是对PUNCH CD3-OLS进行的探索性亚组分析，PUNCH CD3-OLS是一项在美国和加拿大进行的3期开放标签前瞻性研究，旨在评估RBL在有记录的rCDI和并发IBS参与者中的安全性和有效性。

方法

年龄≥18岁、诊断为rCDI且完成SOC抗生素治疗的参与者被纳入本研究。PUNCH CD3-OLS的主要终点是发生RBL或给药相关治疗突发不良事件（TEAE）的参与者数量。次要终点包括8周时的治疗成功和6个月时的持续临床反应。在该亚组分析中，根据RBL给药时的病历记录确认是否存在持续性IBS。

结果

在697名接受RBL治疗的患者中，90名患有合并IBS。给予RBL后，8周内有52名IBS患者（57.8%）和278名无IBS患者（45.8%）发生TEAE。大多数TEAE为轻度（IBS患者中为22.2%，无IBS患者中为20.1%）或中度（IBS患者中为26.7%，无IBS患者中为18.8%）。1名IBS患者报告了严重TEAE（据报告肺炎与RBL无关），26名无IBS患者报告了严重TEAE[其中大多数与既往疾病有关（3.1%）]。在所有参与者中，给予RBL后8周内，68.9%的IBS患者和75.6%的无IBS患者没有CDI腹泻。在治疗成功的参与者中，82.3%的IBS患者和92.2%的无IBS患者在6个月时保持了临床反应。