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Probiotic on Prevention of GBS Vaginal Infection During Pregnancy

NCT03688321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2021-07-01

No results posted yet for this study

Summary

The purpose of this study is to examine whether oral taking Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 from 28th week of gestation can reduce the GBS colonization rate of vagina and rectum in 35-37 weeks pregnant women as well as during laboring who present with GBS-positive at 28 weeks pregnancy. Through the results of our study, we try to investigate the role of probiotics in preventing the unnecessary tests, admission and antibiotic treatment in newborn with GBS-positive mother who deliver fewer than 4 hours after laboring and the influence of improving cervical diagnostics quality for postpartum Pap testing. Investigators hope the findings may have some effects on GBS sepsis and protocols as well as cervical diagnosis.

Conditions

  • Infection, Bacterial

Interventions

DIETARY_SUPPLEMENT

Probiotic capsule GR-1 and RC-14

Study Group will take 2 probiotics capsules containing 1 billion colony forming unit(CFU) of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each before sleep for 18 weeks starting at 28th week gestation

DIETARY_SUPPLEMENT

Placebo capsule

Placebo Group will take 2 placebo capsules before sleep for 18 weeks starting at 28th week gestation

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Ming Ho, MD · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2020-08-30
Completion
2021-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688321 on ClinicalTrials.gov