使用益生菌 (Clostridium butyricum,Enterococcus faecium和Bacillus subtilis;PPP试验) 预防反复的自发早产:为前性,单臂,非盲目,多中心试验的协议
Satoshi Yoneda1, Tohru Kobayashi2, Kayoko Kikuchi3
1Department of Obstetrics and Gynecology, University of Toyama, Toyama, Japan.
JMIR research protocols
|September 9, 2024
概括
这项研究调查了包括Clostridium butyricum在内的口服益生菌是否可以预防复发的自发早产 (sPTD). 这些发现将指导临床实践和对孕妇健康益生菌的未来研究.
科学领域:
- 产科和妇科 产科和妇科
- 微生物组研究 微生物组研究
- 围产儿医学 围产儿医学
背景情况:
- 经常性自发早产 (sPTD) 影响全球27-34%的怀孕,在日本为22.3%.
- 益生菌在预防sPTD方面的有效性尚未确定.
- 一些研究表明,Clostridium spp. 益生菌可以通过诱导调节性T细胞来减少复发性sPTD.
研究的目的:
- 评估口服益生菌的预防作用,特别是包括Clostridium butyricum,对复发性sPTD的预防作用.
- 评估益生菌对具有sPTD史的妇女怀孕关键结果的影响.
主要方法:
- 一个前性的,单臂,非盲目的,多中心试验在日本.
- 招募了345名具有sPTD病史的孕妇.
- 主要终点:怀孕37周前复发性sPTD的发生率;次要终点包括早期怀孕时sPTD的发生率,Clostridium spp. 的比例,以及细菌性阴道炎.
主要成果:
- 该试验于2021年3月至4月获得批准并注册.
- 招聘开始于2021年5月.
- 预计完成日期:2025年3月31日.
结论:
- 这项试验将确定Clostridium butyricum益生菌给药后复发性sPTD的发生率.
- 结果将为预防复发性sPTD的临床管理策略提供信息.
- 结果将指导该领域未来随机对照试验的设计.
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