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Prophylactic Probiotics in Premature Infants

NCT00727363 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 751

Last updated 2011-06-22

No results posted yet for this study

Summary

This study tries to determine whether the oral administration of a specific probiotic (good bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent infections and the development of a severe inflammatory disease of the bowel called necrotizing enterocolitis. The investigators propose that premature infants not given probiotics will colonize their gut with bad bacterias and develop infection.

Conditions

  • Death
  • Nosocomial Infection

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri

Lactobacillus reuteri DSM 17938 will be administered at a dose of ten to the eighth colony-forming units in 5 drops of a commercially available oil suspension once per day until discharge from the hospital.

DIETARY_SUPPLEMENT

Placebo

5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital.

Sponsors & Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    collaborator OTHER_GOV

  • Vanderbilt University

    collaborator OTHER

  • Colombian Neonatal Research Network

    lead OTHER

Principal Investigators

  • Mario A Rojas, MD, MPH · Vanderbilt University

  • Juan M Lozano, MD, Msc · Universidad Javeriana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-06-30
Completion
2011-08-31

Countries

  • Colombia

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 NCT00727363 on ClinicalTrials.gov