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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01181791
Study type Interventional
Source University of Miami
Contact
Status Terminated
Phase N/A
Start date July 2010
Completion date July 2017

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