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NCT01891604 Clinical Trial

Study the Safety and Efficacy of Probiotics Use in Premature Infants

Infant, Premature, Diseases Clinical Trial

Official title:
Study the Safety and Efficacy of Probiotics Use in Premature Infants

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01891604
Other study ID # jamesfriel2013
Secondary ID
Status Withdrawn
Phase N/A
First received June 26, 2013
Last updated May 11, 2017

Study information
Verified date May 2017
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• breast milk with Bifidobacterium Longum subp. Infantis R0033

• breast milk

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Manitoba Lallemand Health Solutions

Outcome
Type Measure Description Time frame Safety issue
Primary Calprotectin will be used to determine the effect for probiotics day1 and day30 of the observation
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