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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Abbott Nutrition.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01191112
First received: August 27, 2010
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Stool frequency [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Frequency and intensity of irritability, vomiting, distension [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Energy Intake [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Anthropometrics [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Medication Use [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: January 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (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

  Eligibility

Ages Eligible for Study:   1 Year to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01191112

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

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01191112     History of Changes
Other Study ID Numbers: BK87
Study First Received: August 27, 2010
Last Updated: November 1, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014