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Effects of Lactobacillus Reuteri in Premature Infants (Reuteri)

Primary Purpose

Premature Infant Disease

Status
Terminated
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Lactobacillus reuteri
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Infant Disease focused on measuring probiotics, premature infants, feeding tolerance

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Sotero del Rio
  • Pontifica Universidad Catolica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

probiotic group

Placebo

Arm Description

Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day

The placebo consists of an identical formulation except that the L. reuteri is not present.

Outcomes

Primary Outcome Measures

Time to reach full feeds
Days to reach full feeds from the day feeds are started

Secondary Outcome Measures

Intestinal colonization
PCR quantification of lactobacillus reuteri in the stools
Intestinal immunological response
Quantification immunological markers in the stools

Full Information

First Posted
August 2, 2010
Last Updated
August 24, 2017
Sponsor
University of Miami
Collaborators
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT01181791
Brief Title
Effects of Lactobacillus Reuteri in Premature Infants
Acronym
Reuteri
Official Title
Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant Disease
Keywords
probiotics, premature infants, feeding tolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Administration of probiotic Lactobacillus Reuteri
Masking
ParticipantCare ProviderInvestigator
Masking Description
Administration of placebo
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
probiotic group
Arm Type
Experimental
Arm Description
Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo consists of an identical formulation except that the L. reuteri is not present.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri
Intervention Description
Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo consists of an identical formulation except that the L. reuteri is not present.
Primary Outcome Measure Information:
Title
Time to reach full feeds
Description
Days to reach full feeds from the day feeds are started
Time Frame
First 40 days after birth
Secondary Outcome Measure Information:
Title
Intestinal colonization
Description
PCR quantification of lactobacillus reuteri in the stools
Time Frame
0-6 months after birth
Title
Intestinal immunological response
Description
Quantification immunological markers in the stools
Time Frame
0-6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa del Moral, MD, MPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sotero del Rio
City
Santiago
Country
Chile
Facility Name
Pontifica Universidad Catolica
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33058137
Citation
Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Results Reference
derived

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Effects of Lactobacillus Reuteri in Premature Infants

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