Effects of Lactobacillus Reuteri in Premature Infants

University of Miami65 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Premature Infant Disease

Interventions

Lactobacillus reuteriDIETARY_SUPPLEMENT

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

PlaceboOTHER

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

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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

Locations (2)

Hospital Sotero del Rio

Santiago, Chile

Pontifica Universidad Catolica

Santiago, Chile

Outcomes

Primary Outcomes

Time to reach full feeds

Days to reach full feeds from the day feeds are started

Time frame: First 40 days after birth

Secondary Outcomes

Intestinal colonization

PCR quantification of lactobacillus reuteri in the stools

Time frame: 0-6 months after birth

Intestinal immunological response

Quantification immunological markers in the stools

Time frame: 0-6 months

Data from ClinicalTrials.gov

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