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Effects of Lactobacillus Reuteri in Premature Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Miami
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Teresa del Moral, University of Miami
ClinicalTrials.gov Identifier:
NCT01181791
First received: August 2, 2010
Last updated: October 31, 2014
Last verified: October 2014
  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 Infant Disease
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:


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 2015
Estimated Primary Completion Date: August 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Teresa del Moral, MD 3055856408 tdelmoral@miami.edu
Contact: Patricia Mena, MD

Locations
Chile
Hospital Sotero del Rio Terminated
Santiago, Chile
Pontifica Universidad Catolica Recruiting
Santiago, Chile
Contact: Paulina Toso, MD         
Principal Investigator: Paulina Toso, MD         
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, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01181791     History of Changes
Other Study ID Numbers: 20090924
Study First Received: August 2, 2010
Last Updated: October 31, 2014
Health Authority: United States: Institutional Review Board
Chile: Instituto de Salud Pública de Chile

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

Additional relevant MeSH terms:
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on November 27, 2014