Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

This study is currently recruiting participants.

Verified by Oswaldo Cruz Foundation, March 2006

Sponsors and Collaborators:	Oswaldo Cruz Foundation Dep.Science and Technology of the Brazilian Health Ministry
Information provided by:	Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:	NCT00303082

Purpose

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.

Condition	Intervention	Phase
Bacterial Vaginosis Premature Birth Sepsis Periventricular Leukomalacia Bronchopulmonary Dysplasia	Drug: Lactobacillus rhamnosus GR1 and Lactobacillus reuteri RC-14	Phase III

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Trial for the Prevention of Premature Birth and Neonatal Related Morbidity

Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:

Spontaneous premature birth (<37, <35, <32 weeks of pregnancy) and related neonatal events: early sepsis, bronchopulmonary dysplasia, cystic periventricular leukomalacia, ventricular hemorrhage and retinopathy, besides death.

Secondary Outcome Measures:

Significant occurrence of adverse events
Variation in Nugent Score (before/after intervention)
Variation in selected cytokine levels(before/after
intervention)
Average hospital stay

Estimated Enrollment:	2000
Study Start Date:	January 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Exclusion Criteria:

major malformations in present pregnancy
cervical cerclage
symptomatic vaginosis
insulin dependent diabetes
arterial hypertension
Multiple gestation
Antibiotic therapy in present pregnancy
Syphilis or gonorrhea in present pregnancy
asthma requiring chronic or intermittent therapy
corticotherapy(recent or chronic)
perinatal hemolytic disease
Systemic Erit. Lupus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303082

Contacts

Contact: Leticia Krauss-Silva, MD	5521 25982606	leticiak@ensp.fiocruz.br
Contact: Maria Rosa R Batista, Nurse	5521 25541808	mrosa@iff.fiocruz.br

Locations

Brazil
Hospital Maternidade Carmela Dutra	Recruiting
Rio de Janeiro, Brazil
Contact: Sidney R Mattos Júnior, MD (55 21) 2597-3552 sidneyjr01@ig.com.br
Contact: Glaucia M Prearo, Nurse (5521) 22895398 ext --
Principal Investigator: Sidney R Mattos Júnior, MD
Hospital Maternidade Alexander Fleming	Recruiting
Rio de Janeiro, Brazil
Contact: Antonio Carlos F D'Oro, MD (5521) 24502580 ext -- alexandre.mendes@superig.com.br
Contact: Karla G Camacho, Nurse (5521) 25935289 ext -- pequenakgc@yahoo.com.br
Principal Investigator: Antonio Carlos F D'Oro, MD

Sponsors and Collaborators

Oswaldo Cruz Foundation

Dep.Science and Technology of the Brazilian Health Ministry

Investigators

Principal Investigator:

Leticia Krauss-Silva, MD, Ph.D

Oswaldo Cruz Foundation

More Information

Publications:

Andrews WW. Cervicovaginal cytokines, vaginal infection, and preterm birth. Am J Obstet Gynecol. 2004 May;190(5):1179. No abstract available.

Study ID Numbers:	MDTP2/PDTSP-SUS
Study First Received:	March 13, 2006
Last Updated:	March 16, 2006
ClinicalTrials.gov Identifier:	NCT00303082
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Oswaldo Cruz Foundation:

Probiotics
Bacterial Vaginosis
Premature birth
Intra-uterine Infection
Periventricular leukomalacia

Study placed in the following topic categories:

Bronchopulmonary dysplasia
Bacterial Infections
Pregnancy Complications
Obstetric Labor, Premature
Vaginitis
Obstetric Labor Complications
Vascular Diseases
Central Nervous System Diseases
Vaginal Diseases
Infant, Premature, Diseases
Brain Diseases
Cerebrovascular Disorders

Leukomalacia, Periventricular
Genital Diseases, Female
Bronchopulmonary Dysplasia
Sepsis
Vaginosis, Bacterial
Respiratory Tract Diseases
Encephalomalacia
Lung Diseases
Leukomalacia
Infant, Newborn, Diseases
Premature Birth

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009