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Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

NCT00303082 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2011-06-15

No results posted yet for this study

Summary

The trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection. The tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The study hypothesis is that the early administration of those probiotics to pregnant women with bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of the immune response to infection.

Conditions

  • Bacterial Vaginosis
  • Premature Birth
  • Sepsis
  • Periventricular Leukomalacia
  • Bronchopulmonary Dysplasia

Interventions

DRUG

Lactobacillus rhamnosus GR1 and Lactobacillus reuteri RC-14

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • Leticia Krauss-Silva, MD, Ph.D · Oswaldo Cruz Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-01-31
Completion
2009-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT00303082 on ClinicalTrials.gov