Overview

This trial is active, not recruiting.

Condition premature infant disease
Treatments lactobacillus reuteri, placebo
Phase phase 2
Sponsor University of Miami
Collaborator Pontificia Universidad Catolica de Chile
Start date July 2010
End date August 2016
Trial size 120 participants
Trial identifier NCT01181791, 20090924

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day
lactobacillus reuteri
Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day
(Placebo Comparator)
The placebo consists of an identical formulation except that the L. reuteri is not present.
placebo
The placebo consists of an identical formulation except that the L. reuteri is not present.

Primary Outcomes

Measure
Time to reach full feeds
time frame: First 40 days after birth

Secondary Outcomes

Measure
Intestinal colonization
time frame: 0-6 months after birth
Intestinal immunological response
time frame: 0-6 months

Eligibility Criteria

Male or female participants up to 6 months old.

Inclusion Criteria: - Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days Exclusion Criteria: - Chromosomal anomalies. - Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia) - Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention - Parental refusal - Prior enrollment into a conflicting clinical trial

Additional Information

Official title Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
Principal investigator Teresa del Moral, MD, MPH
Description The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Miami.