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Effects of Lactobacillus Reuteri in Premature Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Miami.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01181791
First received: August 2, 2010
Last updated: August 12, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Premature Infants
 Dietary Supplement: Lactobacillus reuteri
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Time to reach full feeds [ Time Frame: First 40 days after birth ] [ Designated as safety issue: No ]
    Days to reach full feeds from the day feeds are started


Secondary Outcome Measures:
  • Intestinal colonization [ Time Frame: 0-6 months after birth ] [ Designated as safety issue: No ]
    PCR quantification of lactobacillus reuteri in the stools

  • Intestinal immunological response [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
    Quantification immunological markers in the stools


Estimated Enrollment: 120
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: probiotic group
Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day
 Dietary Supplement: Lactobacillus reuteri
Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day
Placebo Comparator: Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present.
 Other: Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present.

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

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181791

Locations
Chile
Pontifica Universidad Catolica
Santiago, Chile
Hospital Sotero del Rio
Santiago, Chile
Sponsors and Collaborators
University of Miami
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Teresa del Moral, MD, MPH University of Miami
  More Information

No publications provided

Responsible Party: Teresa del Moral, Univerisity of Miami
ClinicalTrials.gov Identifier: NCT01181791     History of Changes
Other Study ID Numbers: 20090924
Study First Received: August 2, 2010
Last Updated: August 12, 2010
Health Authority: United States: Institutional Review Board
Chile: Instituto de Salud Publica de Chile

Keywords provided by University of Miami:
probiotics
premature infants
feeding tolerance

ClinicalTrials.gov processed this record on May 19, 2013