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Effects of Lactobacillus Reuteri in Premature Infants

NCT01181791 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-08-28

No results posted yet for this study

Summary

This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.

The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.

Conditions

  • Premature Infant Disease

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri

Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day

OTHER

Placebo

The placebo consists of an identical formulation except that the L. reuteri is not present.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Teresa del Moral, MD, MPH · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Chile

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 NCT01181791 on ClinicalTrials.gov