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

Phase 3

Completed

• Conditions: Gastrointestinal Diseases; Feeding Intolerance
• Interventions: Other: Peptide based enteral formula

• Registration Number: NCT01191112
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-27
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Study Start: 2011-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peptide Based enteral formula	Peptide based enteral formula	-

Primary Outcome Measures

Name	Time	Method
Stool frequency	14 Days
Frequency and intensity of irritability, vomiting, distension	14 Days

Secondary Outcome Measures

Name	Time	Method
Medication Use	14 days
Anthropometrics	14 Days
Average Energy Intake	14 Days

Trial Locations

Locations (1)

University of Alberta, Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada