Mei Zubing, Du Peixin, Han Ye, Shao Zhuo, Zheng De
Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Anorectal Disease Institute of Shuguang Hospital, Shanghai, China.
PLoS One. 2025 Jan 24;20(1):e0311799. doi: 10.1371/journal.pone.0311799. eCollection 2025.
Intestinal constipation is a substantive global health concern, significantly impairing patient quality of life. An emerging view is that the gut microbiota plays a critical role in intestinal function, and probiotics could offer therapeutic benefits. This study aims to consolidate evidence from randomized controlled trials (RCTs) that assess the effectiveness of probiotics in modulating microbiota and ameliorating symptoms of constipation.
We will execute a systematic evidence search across Medline (via PubMed), Embase, Cochrane CENTRAL, Web of Science, Scopus, and CINAHL, employing explicit search terms and further reference exploration. Two independent reviewers will ensure study selection and data integrity while assessing methodological quality via the Cochrane Collaboration's Risk of Bias-2 tool. Our primary goal is to outline changes in microbiota composition, with secondary outcomes addressing symptom relief and stool characteristics. Meta-analyses will adopt a random-effects model to quantify the effects of interventions, supplemented by subgroup analyses and publication bias assessments to fortify the rigor of our findings.
This study endeavors to provide a rigorous, synthesized overview of the probiotics interventions evidence for modulating gut microbiota in individuals with intestinal constipation. The insights derived could inform clinical guidelines, nurture the creation of novel constipation management strategies, and direct future research in this field.
As this study aggregates and analyzes existing data without direct human subject involvement, no ethical approval is required. We will disseminate the study's findings through scientific forums and seek publication in well-regarded, peer-reviewed journals.
OSF registration number: 10.17605/OSF.IO/MEAHT.
肠道便秘是一个重大的全球健康问题，严重损害患者的生活质量。一种新出现的观点认为，肠道微生物群在肠道功能中起关键作用，益生菌可能具有治疗益处。本研究旨在整合随机对照试验（RCT）的证据，这些试验评估了益生菌在调节微生物群和改善便秘症状方面的有效性。
我们将通过明确的检索词，在Medline（通过PubMed）、Embase、Cochrane CENTRAL、Web of Science、Scopus和CINAHL中进行系统的证据检索，并进一步探索参考文献。两名独立的评审员将确保研究的选择和数据的完整性，同时通过Cochrane协作网的偏倚风险-2工具评估方法学质量。我们的主要目标是概述微生物群组成的变化，次要结果涉及症状缓解和粪便特征。荟萃分析将采用随机效应模型来量化干预措施的效果，并辅以亚组分析和发表偏倚评估，以加强我们研究结果的严谨性。
本研究致力于对益生菌干预措施在调节肠道便秘患者肠道微生物群方面的证据进行严谨、综合的概述。由此得出的见解可为临床指南提供参考，促进新型便秘管理策略的制定，并指导该领域的未来研究。
由于本研究汇总和分析现有数据，不涉及直接的人类受试者，因此无需伦理批准。我们将通过科学论坛传播本研究的结果，并寻求在备受认可、同行评审的期刊上发表。
OSF注册号：10.17605/OSF.IO/MEAHT。
