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Effects of Lactobacillus Reuteri in Premature Infants (Reuteri)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181791
Recruitment Status : Terminated (Poor recruitment)
First Posted : August 13, 2010
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Teresa del Moral, University of Miami

Study Description
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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.


Condition or disease Intervention/treatment Phase
Premature Infant Disease Dietary Supplement: Lactobacillus reuteri Other: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Administration of probiotic Lactobacillus Reuteri
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Administration of placebo
Primary Purpose: Prevention
Official Title: Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
Study Start Date : July 2010
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to reach full feeds [ Time Frame: First 40 days after birth ]
    Days to reach full feeds from the day feeds are started


Secondary Outcome Measures :
  1. Intestinal colonization [ Time Frame: 0-6 months after birth ]
    PCR quantification of lactobacillus reuteri in the stools

  2. Intestinal immunological response [ Time Frame: 0-6 months ]
    Quantification immunological markers in the stools


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181791


Locations
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Chile
Hospital Sotero del Rio
Santiago, Chile
Pontifica Universidad Catolica
Santiago, Chile
Sponsors and Collaborators
University of Miami
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Teresa del Moral, MD, MPH University of Miami
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Teresa del Moral, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01181791    
Other Study ID Numbers: 20090924
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Teresa del Moral, University of Miami:
probiotics
premature infants
feeding tolerance
Additional relevant MeSH terms:
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Premature Birth
Infant, Premature, Diseases
Obstetric Labor, Premature
 Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases