使用Lactobacillus crispatus口服益生菌预防早产:双盲随机化安慰剂对照试验 (PrePOP研究) 的协议
Gillian A Corbett1, Siobhan Corcoran1, Conor Feehily2
1UCD Perinatal Research Centre, UCD School of Medicine, University College Dublin, National Maternity Hospital, Dublin 2, Ireland; National Maternity Hospital, Dublin 2, Ireland.
Contemporary clinical trials
|December 19, 2024
概括
这项研究研究了一种含有Lactobacillus crispatus的口服益生菌,用于预防自发早产 (sPTB). 其目的是增加L. crispatus在阴道微生物群中的存在,从而有可能降低高风险怀孕中的sPTB风险.
科学领域:
- 微生物学 微生物学
- 产科 产科 产科 产科 产科
- 遗传学 是一个遗传学.
背景情况:
- 预防自发早产 (sPTB) 仍然是一个临床挑战.
- 减少的阴道 Lactobacillus crispatus 与sPTB相关.
- 这项研究解决了有效的sPTB预防策略的需要.
研究的目的:
- 评估含有L. crispatus的口服益生菌对母亲的阴道和肠道微生物群的影响.
- 评估L. crispatus补充剂在患sPTB高风险的孕妇中的疗效.
- 研究益生菌对阴道和肠道微生物组成的直接和间接影响.
主要方法:
- 这是一项双盲,安慰剂控制,随机化试验,涉及126名具有sPTB高风险的妇女.
- 参与者接受了12周的口服补充益生菌 (含有L. crispatus,L. rhamnosus,L. jensenii,L. gasseri) 或安慰剂.
- 使用高通量DNA测序进行阴道和肠道微生物组分析,并评估二次结局,如sPTB率和新生儿结局.
主要成果:
- 主要结局是在12周的益生菌治疗后,在阴道微生物组中检测到L.crispatus.
- 可检测的L. crispatus增加25%是统计学意义的目标.
- 二次结果将评估干预对肠道微生物组,代谢组和临床怀孕结果的影响.
结论:
- 这项随机试验将确定含有L. crispatus的口服益生菌是否能成功增加其阴道丰度.
- 这项研究将探索益生菌对肠道微生物和代谢的影响.
- 这些发现可能为预防自发早产提供了一种新的策略.
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