NCT01181791

Effects of Lactobacillus Reuteri in Premature Infants

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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 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

Conditions

• Premature Infant Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus reuteri	Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day
OTHER	Placebo	The placebo consists of an identical formulation except that the L. reuteri is not present.

Timeline

• Start date: 2010-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2010-08-13
• Last updated: 2017-08-28

Locations

2 sites across 1 country: Chile