Perioperative administration of CBM588 in colorectal cancer radical surgery: A single-center, randomized controlled trial.

IF 11.7 1区医学 Q1 CELL BIOLOGY

Cell Reports Medicine Pub Date : 2025-07-15 Epub Date: 2025-07-08 DOI:10.1016/j.xcrm.2025.102234

Yongzhi Yang, Yangyang Guo, Yan Ding, Jinming Li, Lei Liang, Debing Shi, Xinxiang Li, Yanlei Ma

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引用次数: 0

Abstract

Clostridium butyricum MIYAIRI 588 (CBM588) has been used to treat gastrointestinal disorders and recently found to enhance efficacy of checkpoint inhibitor in solid tumors. However, limited studies spotlight the role of CBM588 in perioperative management of colorectal cancer (CRC) radical surgery. Here, we report a phase 4, open-label, randomized controlled trial (ChiCTR2000033883) to assess the safety and short-term efficacy of CBM588 as a perioperative, adjunctive therapy. The primary efficacy indicator is postoperative intestinal function assessed by time to first flatus, recovery time of defecation, and first intake of delicate fluid and semi-fluid. Secondary outcomes are incidence of postoperative complications and immune status. We find that perioperative administration of CBM588 significantly benefits recovery of intestinal function, lowers risk of infectious complications, and enhances systemic immunity by increasing circulating T cells. CBM588 serves as a promising probiotic with favorable tolerability in CRC patients undergoing radical surgery.

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结直肠癌根治术围手术期给药CBM588：一项单中心、随机对照试验

丁酸梭菌MIYAIRI 588 （CBM588）已被用于治疗胃肠道疾病，最近发现可提高检查点抑制剂在实体瘤中的疗效。然而，有限的研究关注了CBM588在结直肠癌根治性手术围手术期管理中的作用。在这里，我们报告了一项4期、开放标签、随机对照试验（ChiCTR2000033883），以评估CBM588作为围手术期辅助治疗的安全性和短期疗效。主要疗效指标为术后肠功能，以首次排气时间、排便恢复时间、首次摄入细嫩液体和半流质液体评估。次要结局是术后并发症的发生率和免疫状态。我们发现围手术期给予CBM588显著有利于肠道功能的恢复，降低感染并发症的风险，并通过增加循环T细胞增强全身免疫。CBM588作为一种有前景的益生菌，在接受根治性手术的CRC患者中具有良好的耐受性。

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

Cell Reports Medicine Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)

CiteScore

15.00

自引率

1.40%

发文量

231

审稿时长

40 days

期刊介绍： Cell Reports Medicine is an esteemed open-access journal by Cell Press that publishes groundbreaking research in translational and clinical biomedical sciences, influencing human health and medicine. Our journal ensures wide visibility and accessibility, reaching scientists and clinicians across various medical disciplines. We publish original research that spans from intriguing human biology concepts to all aspects of clinical work. We encourage submissions that introduce innovative ideas, forging new paths in clinical research and practice. We also welcome studies that provide vital information, enhancing our understanding of current standards of care in diagnosis, treatment, and prognosis. This encompasses translational studies, clinical trials (including long-term follow-ups), genomics, biomarker discovery, and technological advancements that contribute to diagnostics, treatment, and healthcare. Additionally, studies based on vertebrate model organisms are within the scope of the journal, as long as they directly relate to human health and disease.