Department of Obstetrics and Gynecology, University of Toyama, Toyama, Japan.
Department of Data Science, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
JMIR Res Protoc. 2024 Sep 9;13:e59928. doi: 10.2196/59928.
The rate of recurrent spontaneous preterm delivery (sPTD) ranges between 27% and 34% and is 22.3% in Japan. Although it currently remains unclear whether probiotics prevent sPTD, retrospective studies recently reported a reduction in the rate of recurrent sPTD with the administration of probiotics including Clostridium spp., which induce regulatory T cells that play an important role in maintaining pregnancy.
The objective of this trial is to evaluate the preventative effects of available oral probiotics, including Clostridium butyricum, on recurrent sPTD.
This is a prospective, single-arm, nonblinded, multicenter trial in Japan. The sample size required for this trial is 345 pregnant women with a history of sPTD, considering a clinically significant reduction in the relative risk of 30% (risk ratio=0.7). The primary endpoint is the rate of recurrent sPTD at <37 weeks of gestation. The secondary endpoints are the rate of sPTD at <34 weeks of gestation, the rate of recurrent sPTD at <28 weeks of gestation, the ratio of intestinal Clostridium spp. (detected by next-generation sequencing), and bacterial vaginosis (using the Nugent score).
The trial procedures were approved by the Clinical Research Review Board of Toyama University Hospital (SCR2020008) on March 31, 2021. The trial was registered on the Japan Registry of Clinical Trial website on April 28, 2021. Recruitment began on May 1, 2021, and the trial is estimated to finish on March 31, 2025.
The findings will clarify the rate of recurrent sPTD following probiotic administration including Clostridium butyricum. Outcomes from this trial will inform clinical practice and guide future randomized controlled trials.
Japan Registry of Clinical Trials jRCTs041210014; https://jrct.niph.go.jp/latest-detail/jRCTs041210014.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59928.
复发性自发性早产（sPTD）的发生率在 27%至 34%之间，在日本为 22.3%。虽然目前尚不清楚益生菌是否能预防 sPTD，但最近的回顾性研究报告称，使用包括梭状芽孢杆菌属在内的益生菌可以减少复发性 sPTD 的发生率，因为梭状芽孢杆菌属可以诱导发挥重要妊娠维持作用的调节性 T 细胞。
本试验旨在评估包括丁酸梭菌在内的现有口服益生菌预防复发性 sPTD 的效果。
这是一项在日本进行的前瞻性、单臂、非盲、多中心试验。考虑到相对风险降低 30%（风险比=0.7）具有临床意义，本试验需要 345 名有 sPTD 病史的孕妇。主要终点是<37 孕周的复发性 sPTD 发生率。次要终点是<34 孕周的 sPTD 发生率、<28 孕周的复发性 sPTD 发生率、肠道梭状芽孢杆菌属（通过下一代测序检测）的比例和细菌性阴道病（使用 Nugent 评分）。
试验程序于 2021 年 3 月 31 日获得富山大学医院临床研究审查委员会的批准（SCR2020008）。试验于 2021 年 4 月 28 日在日本临床试验注册网站注册。招募于 2021 年 5 月 1 日开始，试验预计于 2025 年 3 月 31 日结束。
这些发现将阐明包括丁酸梭菌在内的益生菌治疗后 sPTD 的复发率。本试验的结果将为临床实践提供信息，并指导未来的随机对照试验。
日本临床试验注册 jRCTs041210014；https://jrct.niph.go.jp/latest-detail/jRCTs041210014。
国际注册报告标识符（IRRID）：DERR1-10.2196/59928。
