Premature Infant Disease Clinical Trial
Official title:
Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
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 ;
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