Effects of Lactobacillus Reuteri in Premature Infants
This trial is active, not recruiting.
|Condition||premature infant disease|
|Treatments||lactobacillus reuteri, placebo|
|Sponsor||University of Miami|
|Collaborator||Pontificia Universidad Catolica de Chile|
|Start date||July 2010|
|End date||August 2016|
|Trial size||120 participants|
|Trial identifier||NCT01181791, 20090924|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Time to reach full feeds
time frame: First 40 days after birth
time frame: 0-6 months after birth
Intestinal immunological response
time frame: 0-6 months
Male or female participants up to 6 months old.
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
|Official title||Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns|
|Principal investigator||Teresa del Moral, MD, MPH|
|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|
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