Clinical Trial: Effects of Lactobacillus Reuteri in Premature Infants

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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.


Detailed Summary: 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
Sponsor: University of Miami

Current Primary Outcome: Time to reach full feeds [ Time Frame: First 40 days after birth ]

Days to reach full feeds from the day feeds are started


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intestinal colonization [ Time Frame: 0-6 months after birth ]
    PCR quantification of lactobacillus reuteri in the stools
  • Intestinal immunological response [ Time Frame: 0-6 months ]
    Quantification immunological markers in the stools


Original Secondary Outcome: Same as current

Information By: University of Miami

Dates:
Date Received: August 2, 2010
Date Started: July 2010
Date Completion: May 2017
Last Updated: May 9, 2017
Last Verified: May 2017