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Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy

NCT01697683 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2014-03-24

No results posted yet for this study

Summary

This study will add to the current knowledge and literature on the ability of an oral lactobacilli preparation to return the vaginal flora to a normal state in pregnant women. The results will potentially serve as the basis for a multi-centre Phase III randomized clinical trial to determine the efficacy of this treatment in preventing preterm birth.

Conditions

  • Pregnant Women Who Test Positive for Bacterial Vaginosis

Interventions

DRUG

Probiotic Lactobacilli

Two capsules per day containing either probiotic lactobacilli or placebo for 12 weeks

DRUG

Placebo

Sponsors & Collaborators

  • Unity Health Toronto

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Alan Bocking, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT01697683 on ClinicalTrials.gov