Prevention of Recurrent Spontaneous Preterm Delivery Using Probiotics (Clostridium butyricum, Enterococcus faecium, and Bacillus subtilis; PPP Trial): Protocol for a Prospective, Single-Arm, Nonblinded, Multicenter Trial

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 i...

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Bibliographic Details
Published in:JMIR research protocols 2024-09, Vol.13, p.e59928
Main Authors: Yoneda, Satoshi, Kobayashi, Tohru, Kikuchi, Kayoko, Iwamoto, Shintaro, Teramoto, Tsuyoshi, Chujo, Daisuke, Otsuki, Katsufumi, Nakai, Akihito, Saito, Shigeru
Format: Article
Language:English
Subjects:
Adult
Clinical trials
Clostridium butyricum
Cohort analysis
Constipation
Diabetes
Disease prevention
Edema
Female
Humans
Infections
Inflammation
Informed consent
Japan
Multicenter Studies as Topic
Newborn babies
Prebiotics
Pregnancy
Premature birth
Premature Birth - prevention & control
Probiotics
Probiotics - administration & dosage
Probiotics - therapeutic use
Prospective Studies
Protocol
Recurrence
Registration
Womens health
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Summary: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
ISSN:1929-0748
1929-0748
DOI:10.2196/59928