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ORIGINAL RESEARCH article

Front. Pharmacol.

Sec. Gastrointestinal and Hepatic Pharmacology

Volume 16 - 2025 | doi: 10.3389/fphar.2025.1688544

Efficacy and safety of Live Combined Bacillus subtilis and Enterococcus faecium in patients with constipation: a meta-analysis of randomized controlled trials

Provisionally accepted
Wenwen  LiWenwen LiYingying  LiangYingying LiangGuangcai  LiGuangcai LiDandan  YangDandan YangXiaoqian  ZhangXiaoqian Zhang*
  • Affiliated Hospital of Shandong Second Medical University, Weifang, China

The final, formatted version of the article will be published soon.

Background: Live Combined Bacillus subtilis and Enterococcus faecium (LCBE) provides favorable clinical benefits in patients with constipation, while there lacks a comprehensive evaluation. This meta-analysis aimed to comprehensively evaluate the efficacy and safety of LCBE in patients with constipation. Methods: Randomized controlled trials assessing the efficacy or safety of LCBE in patients with constipation published before September 2025 were comprehensively searched in Wan Fang, China National Knowledge Infrastructure, China Science and Technology Journal Database, Web of Science, Cochrane Library, and PubMed. Efficacy and safety outcomes were collected. Results: Thirty-two studies were included, containing 1565 cases receiving LCBE plus control treatment (experimental group) and 1490 cases receiving control treatment alone (control group). Experimental group showed higher total effective rate [odds ratio (OR) (95% confidence interval (CI))=5.789 (4.598~7.288), P<0.001], Bristol stool scale score [standardized mean difference (SMD) (95% CI)=2.532 (1.274~3.790), P<0.001], defecation frequency per week [SMD (95% CI)=1.937 (1.252~2.623), P<0.001], and defecation rate within 24 hours [OR (95% CI)=2.545 (1.377~4.705), P=0.003] than control group. The defecation difficulty score tended to reduce in experimental group versus control group, although not reaching statistical significance [SMD (95% CI) =-1.924 (-3.947~0.099), P=0.062]. There was no difference in the total adverse reaction rate between groups [OR (95% CI) =0.703 (0.414~1.191), P=0.190]. Subgroup analyses suggested that LCBE was effective regardless of dosage form or treatment course. All studies were of moderate-to-high quality. Conclusion: LCBE exerts a favorable efficacy with good tolerance in patients with constipation. This meta-analysis provides supportive evidence for its clinical application in constipation.

Keywords: Constipation, Live Combined Bacillus subtilis and Enterococcus faecium, efficacy, Safety, Meta-analysis

Received: 19 Aug 2025; Accepted: 23 Sep 2025.

Copyright: © 2025 Li, Liang, Li, Yang and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Xiaoqian Zhang, zxq13853697396@163.com

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