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

March 2, 2015 updated by: Abbott Nutrition
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2J3
        • University of Alberta, Stollery Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Peptide Based enteral formula
Other: Peptide based enteral formula
Sole source nutrition as per HCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stool frequency
Time Frame: 14 Days
14 Days
Frequency and intensity of irritability, vomiting, distension
Time Frame: 14 Days
14 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Average Energy Intake
Time Frame: 14 Days
14 Days
Anthropometrics
Time Frame: 14 Days
14 Days
Medication Use
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (ESTIMATE)

August 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK87

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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