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A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants

Necrotizing Enterocolitis Clinical Trial

Official title:
A Randomized Controlled Trial on a Multi-strain Synbiotic vs. a Multi-strain Probiotic on Fecal Colonization in the Very Low Birth Weight Infant

Clinical Trial Summary

The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34 weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1, DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24 months CGA.

Clinical Trial Description

Feeding Intolerance and other GI issues are a major concern in a NICU hospitalized population. Successful colonization with probiotic bacteria is thought to impact the incidence of GI related issues. This study will study the impact of prebiotics on the colonization of a population of VLBW infants in the NICU setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01337921
Study type Interventional
Source University of Nebraska
Contact
Status Withdrawn
Phase N/A
Start date June 2011
Completion date June 16, 2011
View Details
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