Effects of Lactobacillus Reuteri in Premature Infants

Study Overview
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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.

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

Official Title
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Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns

Conditions
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Premature Infant Disease

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Administration of probiotic Lactobacillus Reuteri
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic group<br>Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day | Dietary Supplement: Lactobacillus reuteri<br>* Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day<br>|
| Placebo Comparator: Placebo<br>The placebo consists of an identical formulation except that the L. reuteri is not present. | Other: Placebo<br>* The placebo consists of an identical formulation except that the L. reuteri is not present.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach full feeds | Days to reach full feeds from the day feeds are started | First 40 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal colonization | PCR quantification of lactobacillus reuteri in the stools | 0-6 months after birth | 
| Intestinal immunological response | Quantification immunological markers in the stools | 0-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, premature infants, feeding tolerance