Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Abbott Nutrition Identifier:
First received: August 27, 2010
Last updated: March 2, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Gastrointestinal Diseases
Feeding Intolerance
Other: Peptide based enteral formula
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Stool frequency [ Time Frame: 14 Days ]
  • Frequency and intensity of irritability, vomiting, distension [ Time Frame: 14 Days ]

Secondary Outcome Measures:
  • Average Energy Intake [ Time Frame: 14 Days ]
  • Anthropometrics [ Time Frame: 14 Days ]
  • Medication Use [ Time Frame: 14 days ]

Enrollment: 27
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peptide Based enteral formula Other: Peptide based enteral formula
Sole source nutrition as per HCP


Ages Eligible for Study:   1 Year to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01191112

Canada, Alberta
University of Alberta, Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G2J3
Sponsors and Collaborators
Abbott Nutrition
Study Chair: Jennifer Williams, MPH Abbott Nutrition
  More Information

Responsible Party: Abbott Nutrition Identifier: NCT01191112     History of Changes
Other Study ID Numbers: BK87
Study First Received: August 27, 2010
Last Updated: March 2, 2015

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases processed this record on May 25, 2017