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Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women

NCT04638257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-11-20

No results posted yet for this study

Summary

Bacterial vaginosis (BV) occurs in about 20% of pregnancies and responsible for up to 25% of visits to gynecological clinics. BV is characterized by a shift in vaginal bacterial flora from lactobacilli to pathogenic bacterial flora like Gardnerella and Mycoplasma. Risk factors for the development of BV include douching, use of intrauterine contraceptive devices, new or multiple sexual partners, smoking and African American background.

Conditions

  • Bacterial Vaginosis

Interventions

BIOLOGICAL

Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14

Daily oral Lactobacilli starting at =\<18 weeks of gestation in singleton pregnancy

OTHER

Placebo

Daily oral placebo starting at =\<18 weeks of gestation in singleton pregnancy

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Sunil K Jain, MD · University of Texas Medical Branch at Galveston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

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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 NCT04638257 on ClinicalTrials.gov