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Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery

NCT00217308 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-08-31

No results posted yet for this study

Summary

Purpose of the study is to determine the effect of probiotic lactobacilli on the vaginal flora and cytokine profile during pregnancy, and the incidence of preterm labour in women at high risk for preterm birth.

Conditions

  • Premature Birth
  • Bacterial Vaginosis

Interventions

DRUG

Lactobacilli GR-1 and RC-14

Probiotic Lactobacilli will be compared to placebo

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Alan Bocking, MD, FRCSC · Chief, Department of Obstetrics and Gynaecology, 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
2005-02-28
Primary Completion
2007-07-31
Completion
2007-09-30

Countries

  • Canada

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 NCT00217308 on ClinicalTrials.gov