Study the Safety and Efficacy of Probiotics Use in Premature Infants

NCT ID: NCT01891604

Last Updated: 2017-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity.

Detailed Description

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Conditions

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Infant, Premature, Diseases

Study Design

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Intervention Model

PARALLEL

Interventions

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breast milk with Bifidobacterium Longum subp. Infantis R0033

Intervention Type DIETARY_SUPPLEMENT

breast milk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* born with weight\<1500 g
* hospitalized within 48 hours after birth

Exclusion Criteria

* present with evidence or suspicion of congenital intestinal obstruction
* perforation
* gastroschisis
* large omphalocele
* congenital diaphragmatic hernia
* major congenital heart defects
Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lallemand Health Solutions

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. James Friel

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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jamesfriel2013

Identifier Type: -

Identifier Source: org_study_id

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