Status:
COMPLETED
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Lead Sponsor:
Abbott Nutrition
Conditions:
Gastrointestinal Diseases
Feeding Intolerance
Eligibility:
All Genders
1-13 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01191112
Start Date
January 1 2011
End Date
November 1 2011
Last Update
March 3 2015
Active Locations (1)
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1
University of Alberta, Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G2J3