产丁酸共生菌介导中药JCM-16021对腹泻型肠易激综合征腹痛的疗效：一项随机临床试验

IF 6.7 1区医学 Q1 CHEMISTRY, MEDICINAL

Phytomedicine Pub Date : 2025-07-01 DOI:10.1016/j.phymed.2025.157040

Lixiang Zhai , Ya Zheng , Cho Wing Lo , Shujun Xu , Xuanting Jiang , Qin Liu , Jessica YL Ching , Ziwan Ning , Gengyu Bao , Wei Yang , Qiuqin Zhang , Chung Wah Cheng , Wai Ching Lam , Kam Leung Chan , Xuan Zhang , Pui Yan Lam , Xing Yao Wu , Linda L.D. Zhong , Pei Hua Cao , Matthew Koh , Zhaoxiang Bian

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引用次数: 0

摘要

背景：易泻性肠综合征伴腹泻（IBS-D）的治疗面临着巨大的挑战，因为有效靶向潜在病理生理机制的治疗方案有限。在这项研究中，我们进行了一项多中心，双盲，随机安慰剂对照试验，研究草药JCM-16021对IBS-D的疗效和安全性，重点关注其对肠道微生物群的影响。结果本研究评估了JCM-16021缓解IBS-D患者腹痛的临床疗效和安全性。结果表明JCM-16021有效且安全，其治疗效果与调节短链脂肪酸（SCFA）的产生密切相关。通过小鼠粪便微生物群移植（FMT）实验，我们发现SCFA产生物介导JCM-16021治疗后腹痛症状的缓解。在tnbs诱导的IBS小鼠模型中，我们发现JCM-16021富集的丁酸酯生成物可显著改善腹痛。重要的是，IBS-D患者的基线肠道微生物特征，如直肠真杆菌的存在，可以预测他们对JCM-16021治疗的反应。结论JCM-16021不仅具有缓解IBS-D患者腹痛的作用，而且具有菌群依赖机制，强调了调节肠道菌群对胃肠道疾病的治疗潜力。通过将人体临床试验与小鼠生物学实验相结合，本研究建立了一种研究肠道微生物群在草药治疗中的作用的转化方法。

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Butyrate-producing commensal bacteria mediates the efficacy of herbal medicine JCM-16021 on abdominal pain in diarrhea-predominant irritable bowel syndrome: a randomized clinical trial

Background

Irritable bowel syndrome with diarrhea (IBS-D) presents significant treatment challenges due to limited therapeutic options that effectively target the underlying pathophysiological mechanisms. In this study, we performed a multi-center, double-blind randomized placebo-controlled trial to investigate the efficacy and safety of herbal medicine JCM-16021 on IBS-D with a focus on its effects on gut microbiota.

Results

Our study assessed the clinical efficacy and safety of JCM-16021 in alleviating abdominal pain in IBS-D patients. The results suggested that JCM-16021 is both effective and safe, with its therapeutic effects closely linked to the modulation of short-chain fatty acid (SCFA) producers. Through fecal microbiota transplantation (FMT) experiments in mice, we showed that SCFA producers mediate the alleviation of abdominal pain symptoms by the JCM-16021 treatment. In a TNBS-induced mouse model of IBS, we showed that butyrate producers enriched by JCM-16021 significantly ameliorate abdominal pain. Importantly, baseline gut microbial profiles, such as the presence of Eubacterium rectale in IBS-D patients are predictive of their responses to JCM-16021 treatment.

Conclusions

Our findings not only affirm the efficacy of JCM-16021 in mitigating abdominal pain in IBS-D patients but also highlight a microbiota-dependent mechanism, underscoring the therapeutic potential of gut microbiota modulation in treating gastrointestinal disorders. By combining clinical trials in humans with biological experiments in mice, this study establishes a translational approach to investigate the role of gut microbiota in the treatment of herbal medicine.

ClinicalTrials.gov no: NCT03457324.

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来源期刊

Phytomedicine 医学-药学

CiteScore

10.30

自引率

5.10%

发文量

670

审稿时长

91 days

期刊介绍： Phytomedicine is a therapy-oriented journal that publishes innovative studies on the efficacy, safety, quality, and mechanisms of action of specified plant extracts, phytopharmaceuticals, and their isolated constituents. This includes clinical, pharmacological, pharmacokinetic, and toxicological studies of herbal medicinal products, preparations, and purified compounds with defined and consistent quality, ensuring reproducible pharmacological activity. Founded in 1994, Phytomedicine aims to focus and stimulate research in this field and establish internationally accepted scientific standards for pharmacological studies, proof of clinical efficacy, and safety of phytomedicines.