Study the Safety and Efficacy of Probiotics Use in Premat... | NCT01891604

Studies
Study the Safety and Efficacy of Probiotics Use in Premature Infants

NCT01891604

Sponsor

University of Manitoba

Status

Withdrawn

Last Update Posted

May 12, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Infant, Premature, Diseases

Interventions

breast milk with Bifidobacterium Longum subp. Infantis R0033
breast milk

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study Never Initiated due to Impact approval from institution not being obtinaed

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Dec 2016Estimated

Completion Date

Not provided

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jun 28, 2013

First Posted Date

Jul 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2017

Last Update Posted Date

May 12, 2017Actual

Name	Class
Lallemand Health Solutions	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Calprotectin will be used to determine the effect for probiotics		day1 and day30 of the observation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007235	Infant, Premature, Diseases

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008895	Milk, Human

Ancestor Terms

ID	Term
D008892	Milk
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
breast milk with Bifidobacterium Longum subp. Infantis R0033	Dietary Supplement
breast milk	Dietary Supplement