Effects of Lactobacillus Reuteri in Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Premature Infant Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Administration of probiotic Lactobacillus Reuteri

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Administration of placebo

Study Groups

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probiotic group

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

Group Type EXPERIMENTAL

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Lactobacillus reuteri

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No