在怀孕期间口服益生菌补充剂以减少B组链球菌殖民 (OPSiP试验):双盲并行组随机化安慰剂试验的研究协议
Kelly Hayes1,2, Patricia Janssen3, Beth A Payne4,5
1BCCHR, The University of British Columbia, Vancouver, British Columbia, Canada kelly.hayes@bcchr.ca.
BMJ open
|February 5, 2024
概括
这项研究研究益生菌作为抗生素的替代品,用于预防孕妇的B组链球菌 (GBS). 研究人员的目标是在没有广泛使用抗生素的情况下减少GBS殖民和相关的新生儿风险.
科学领域:
- 产科和妇科 产科和妇科
- 微生物学 微生物学
- 临床试验 临床试验
背景情况:
- 乙组链球菌 (GBS) 是新生儿疾病和死亡的主要原因.
- 目前的加拿大指导方针建议对母亲进行普遍查和选择性抗生素使用,从而导致预防性抗生素显著暴露.
- 对抗生素副作用的担忧迫使人们探索替代策略,以减少GBS殖民.
研究的目的:
- 评估一种特定的益生菌配方在降低孕妇GBS殖民率方面的疗效.
- 为了比较益生菌干预组和安慰剂组之间的GBS殖民率.
- 评估二次结果,包括母亲的抗生素暴露和泌尿器官感染.
主要方法:
- 一个双盲,并行组,随机对照试验,涉及450名怀孕的参与者在温哥华,BC.
- 参与者接受了每天口服三种益生菌菌株的剂量或安慰剂.
- 通过在妊娠35周和分娩期间的阴道/直肠拭子来确定GBS殖民状态.
主要成果:
- 主要结果:GBS殖民状态.
- 二次结局:母亲接触抗生素和泌尿器官感染.
- 将使用治疗意向分析.
结论:
- 初步证据表明,益生菌可能会对GBS殖民提供保护.
- 这项试验将提供关于益生菌作为替代预防策略的有效性的关键数据.
- 这些发现将为临床实践提供信息,并可能减少新生儿GBS疾病发病率.
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