CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Probiotic +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01577108
NCT01577108N/ACompleted

Oral Probiotics Lactobacillus Rhamnosus GR-1 and Lactobacillus Reuteri RC-14 Reduce Group B Streptococci Colonization in Pregnant Women

China Medical University Hospital·interventional·Posted Apr 13, 2012·Updated Mar 31, 2017

In Brief

A clinical study evaluating Probiotic and Placebo for Group B Streptococcal Infection. Completed, enrolled 110 participants across 1 site.

Detailed Summary

The purpose of this study is to examine whether daily use of oral gelatin capsules containing dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive diagnosed by GBS culture at 35-37 weeks gestation. This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our out-patient department. Subjects with vagina and rectum GBS colonization are invited to participate in our study after informed consent. A total of 200 pregnant women will participate in the study during the 12-months trial period. They are randomly assigned to one of the two groups. The study group is treated with two oral capsules of probiotics once daily (before sleeping) for 14 days, and the control group will take 2 capsules of placebos. Vaginal and rectal GBS culture is repeated for all participators 2 weeks later. All participators will treated according to GBS guideline by CDC in 2002 during laboring.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2012
Enrollment StartApr 1, 2011
Primary CompletionSep 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.2 years ago

Interventions

Probioticdietary

oral taking 2 capsules before sleeping per day for 14 days

Placebodietary

oral taking 2 capsules before sleeping per day for 14 days