Back to resultsEvaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Primary Purpose
Gastrointestinal Diseases, Feeding Intolerance
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Peptide based enteral formula
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Diseases
Eligibility Criteria
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.
Sites / Locations
- University of Alberta, Stollery Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peptide Based enteral formula
Arm Description
Outcomes
Primary Outcome Measures
Stool frequency
Frequency and intensity of irritability, vomiting, distension
Secondary Outcome Measures
Average Energy Intake
Anthropometrics
Medication Use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01191112
Brief Title
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Official Title
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases, Feeding Intolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peptide Based enteral formula
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Peptide based enteral formula
Intervention Description
Sole source nutrition as per HCP
Primary Outcome Measure Information:
Title
Stool frequency
Time Frame
14 Days
Title
Frequency and intensity of irritability, vomiting, distension
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Average Energy Intake
Time Frame
14 Days
Title
Anthropometrics
Time Frame
14 Days
Title
Medication Use
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Williams, MPH
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alberta, Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2J3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
We'll reach out to this number within 24 hrs