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

IF 5.3 3区医学 Q1 INFECTIOUS DISEASES

Infectious Diseases and Therapy Pub Date : 2025-09-01 Epub Date: 2025-08-10 DOI:10.1007/s40121-025-01208-0

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

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引用次数: 0

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.

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粪便微生物群Live-jslm预防肠易激综合征患者复发性艰难梭菌感染的安全性和有效性

基于微生物群的产品治疗肠易激综合征（IBS）和复发性艰难梭菌感染（rCDI）患者的安全性和有效性尚未研究。粪便微生物群，活菌群（RBL）；REBYOTA®)是fda批准的单剂量、基于微生物群的产品，用于预防标准护理（SOC）抗生素治疗后成人的rCDI。这是PUNCH CD3-OLS的一项探索性亚组分析，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对有记录的rCDI和并发IBS患者的安全性和有效性。方法：年龄≥18岁，诊断为rCDI并完成SOC抗生素治疗的参与者纳入本研究。PUNCH CD3-OLS的主要终点是与RBL或给药相关的治疗不良事件（teae）的参与者数量。次要终点包括8周的治疗成功和6个月的持续临床反应。在这个亚组分析中，基于RBL给药时的医疗记录文件确认了持续的IBS。结果：697例RBL受者中，90例合并IBS。服用RBL后，52名IBS患者（57.8%）和278名非IBS患者（45.8%）在8周内经历了teae。大多数teae为轻度（有肠易激综合征22.2%，无肠易激综合征20.1%）或中度（有肠易激综合征26.7%，无肠易激综合征18.8%）。1名IBS患者（肺炎与RBL无关）和26名非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，68.9%的IBS患者和75.6%的非IBS患者在服用RBL后8周内没有CDI腹泻。在治疗成功的参与者中，82.3%的IBS患者和92.2%的非IBS患者在6个月内保持了持续的临床反应。结论：RBL是预防并发IBS患者CDI复发的一种安全有效的选择。试验注册：ClinicalTrials.gov识别码，NCT03931941。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Infectious Diseases and Therapy Medicine-Microbiology (medical)

CiteScore

8.60

自引率

1.90%

发文量

136

审稿时长

6 weeks

期刊介绍： Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.