NCT01181791

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

7 years

First QC Date

August 2, 2010

Last Update Submit

August 24, 2017

Conditions

Premature Infant Disease

Keywords

probioticspremature infantsfeeding tolerance

Outcome Measures

Primary Outcomes (1)

  • Time to reach full feeds

    Days to reach full feeds from the day feeds are started

    First 40 days after birth

Secondary Outcomes (2)

  • Intestinal colonization

    0-6 months after birth

  • Intestinal immunological response

    0-6 months

Study Arms (2)

probiotic group

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus reuteri

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lactobacillus reuteriDIETARY_SUPPLEMENT

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

probiotic group
PlaceboOTHER

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

Placebo

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Sotero del Rio

Santiago, Chile

Location

Pontifica Universidad Catolica

Santiago, Chile

Location

Related Publications (2)

  • 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. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.

    PMID: 37493095DERIVED

  • 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.

    PMID: 33058137DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Teresa del Moral, MD, MPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Administration of placebo
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Administration of probiotic Lactobacillus Reuteri
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 13, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 28, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CL(2)