Effects of Lactobacillus Reuteri in Premature Infants

Not Applicable

Terminated

• Conditions: Premature Infant Disease
• Interventions: Other: Placebo; Dietary Supplement: Lactobacillus reuteri

• 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

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The placebo consists of an identical formulation except that the L. reuteri is not present.
probiotic group	Lactobacillus reuteri	Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day

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

Trial Locations

Locations (2)

Pontifica Universidad Catolica; 🇨🇱 Santiago, Chile

Hospital Sotero del Rio; 🇨🇱 Santiago, Chile