Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Miami
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- Time to reach full feeds
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Administration of placebo
Eligibility Criteria
- Ages
- — to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days
Exclusion Criteria
- •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
Arms & Interventions
Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present.
Intervention: Placebo (Other)
probiotic group
Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day
Intervention: Lactobacillus reuteri (Dietary Supplement)
Outcomes
Primary Outcomes
Time to reach full feeds
Time Frame: First 40 days after birth
Days to reach full feeds from the day feeds are started
Secondary Outcomes
- Intestinal colonization(0-6 months after birth)
- Intestinal immunological response(0-6 months)
Investigators
Teresa del Moral
Associate Professor
University of Miami