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Prevention of Recurrent Spontaneous Preterm Delivery Using Probiotics (Clostridium butyricum, Enterococcus faecium,

Satoshi Yoneda1, Tohru Kobayashi2, Kayoko Kikuchi3

  • 1Department of Obstetrics and Gynecology, University of Toyama, Toyama, Japan.

JMIR Research Protocols
|September 9, 2024
PubMed

Insights

This study investigates if oral probiotics, including Clostridium butyricum, can prevent recurrent spontaneous preterm birth (sPTD). Findings will guide clinical practice and future research on probiotics for pregnancy health.

Area of Science:

  • Obstetrics and Gynecology
  • Microbiome Research
  • Perinatal Medicine

Background:

  • Recurrent spontaneous preterm delivery (sPTD) affects 27-34% of pregnancies globally and 22.3% in Japan.
  • The efficacy of probiotics in preventing sPTD is not yet established.
  • Some studies suggest Clostridium spp. probiotics may reduce recurrent sPTD by inducing regulatory T cells.

Purpose of the Study:

  • To evaluate the preventative effects of oral probiotics, specifically including Clostridium butyricum, on recurrent sPTD.
  • To assess the impact of probiotics on key pregnancy outcomes in women with a history of sPTD.

Main Methods:

  • A prospective, single-arm, nonblinded, multicenter trial in Japan.
  • Recruitment of 345 pregnant women with a history of sPTD.
  • Primary endpoint: rate of recurrent sPTD before 37 weeks gestation; Secondary endpoints include rates of sPTD at earlier gestations, Clostridium spp. ratio, and bacterial vaginosis.

Main Results:

  • Trial approved and registered in March-April 2021.
  • Recruitment commenced in May 2021.
  • Estimated completion date: March 31, 2025.

Conclusions:

  • This trial will determine the rate of recurrent sPTD after administration of Clostridium butyricum probiotics.
  • Results will inform clinical management strategies for preventing recurrent sPTD.
  • Outcomes will guide the design of future randomized controlled trials in this area.
Abstract

Keywords:
clostridiuminfectionmeta-analysismulticenter open label trialneonatesoral probioticspregnancypregnantpregnant womenpreterm birthspreterm deliveryprobioticsprospective single-armrecurrent spontaneous preterm deliveryspontaneous preterm deliverysystematic review

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