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Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy

NCT01479478 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2018-08-20

Study results available
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Summary

The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal antibiotic administration at time of labor. The importance of this study is that it may offer a safer alternative to antibiotic treatment of group B Streptococcus (GBS) colonized pregnant women.

Conditions

Interventions

DRUG

Placebo

One placebo capsule daily.

DIETARY_SUPPLEMENT

Probiotic dietary supplement

Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Sponsors & Collaborators

Principal Investigators

  • Natali Aziz, MD · Stanford University School of Medicine/Lucile Packard Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2017-07-26
Completion
2017-07-26

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01479478 on ClinicalTrials.gov