Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 26, 2024
Date Accepted: Jul 31, 2024
Prevention of recurrent spontaneous preterm delivery by probiotics (C. butyricum, E. faecium, and B. subtilis) (PPP trial): Protocol for a prospective single-arm, non-blinded, multicenter trial
ABSTRACT
Background:
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 (Treg) cells that play an important role in maintaining pregnancy.
Objective:
The objective of this trial is to evaluate the preventative effects of available oral probiotics, including Clostridium butyricum, on recurrent sPTD.
Methods:
This is a prospective single-arm, non-blinded multicenter trial in Japan. The subjects required for this trial are 345 pregnant women with histories 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 <37 weeks of gestation. The secondary endpoints are the rate of sPTD <34 weeks of gestation, the rate of recurrent sPTD <28 weeks of gestation, the ratio of intestinal Clostridium spp. (next-generation sequencing), and bacterial vaginosis (Nugent score).
Results:
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 (jRCTs041210014) on April 28, 2021. Recruitment began on May 1, 2021, and the trial will finish at approximately March 31, 2025.
Conclusions:
The findings will clarify the rate of recurrent sPTD with probiotics including Clostridium butyricum. Outcomes from this trial will inform clinical practice and guide future randomized controlled trials. Clinical Trial: Japan Registry of Clinical Trials, jRCTs041210014; https://jrct.niph.go.jp/latest-detail/jRCTs041210014
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.