Effects of Lactobacillus Reuteri in Premature Infants
- Conditions
- Premature Infant Disease
- Registration Number
- NCT01181791
- Lead Sponsor
- University of Miami
- 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 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 65
- Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days
- Chromosomal anomalies.
- Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
- Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
- Parental refusal
- Prior enrollment into a conflicting clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to reach full feeds First 40 days after birth Days to reach full feeds from the day feeds are started
- Secondary Outcome Measures
Name Time Method Intestinal colonization 0-6 months after birth PCR quantification of lactobacillus reuteri in the stools
Intestinal immunological response 0-6 months Quantification immunological markers in the stools
Related Research Topics
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Trial Locations
- Locations (2)
Hospital Sotero del Rio
🇨🇱Santiago, Chile
Pontifica Universidad Catolica
🇨🇱Santiago, Chile
Hospital Sotero del Rio🇨🇱Santiago, Chile