Effects of Lactobacillus Reuteri in Premature Infants (Reuteri)

August 24, 2017 updated by: Teresa del Moral, University of Miami

Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Hospital Sotero Del Rio
      • Santiago, Chile
        • Pontifica Universidad Catolica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach full feeds
Time Frame: First 40 days after birth
Days to reach full feeds from the day feeds are started
First 40 days after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal colonization
Time Frame: 0-6 months after birth
PCR quantification of lactobacillus reuteri in the stools
0-6 months after birth
Intestinal immunological response
Time Frame: 0-6 months
Quantification immunological markers in the stools
0-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Teresa del Moral, MD, MPH, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 12, 2010

First Posted (Estimate)

August 13, 2010

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090924

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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