Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population

NCT ID: NCT01191112

Last Updated: 2015-03-03

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.

Detailed Description

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Conditions

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Gastrointestinal Diseases Feeding Intolerance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peptide Based enteral formula

Group Type EXPERIMENTAL

Peptide based enteral formula

Intervention Type OTHER

Sole source nutrition as per HCP

Interventions

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Peptide based enteral formula

Sole source nutrition as per HCP

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or nonpregnant female between 1 and 13 years of age.
* Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance.
* Subject requires enteral tube feeding as sole source of nutrition.

Exclusion Criteria

* History of diabetes.
* Requires artificial ventilation.
* Requires parenteral nutrition.
* Subject has intestinal obstruction.
* Subject is receiving dialysis treatment.
* Subject has an allergy or intolerance to any ingredient in the study product.
Minimum Eligible Age

1 Year

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Williams, MPH

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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University of Alberta, Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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BK87

Identifier Type: -

Identifier Source: org_study_id

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