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

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ClinicalTrials.gov Identifier: NCT01191112
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Feeding Intolerance Other: Peptide based enteral formula Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Study Start Date : January 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: Peptide Based enteral formula Other: Peptide based enteral formula
Sole source nutrition as per HCP




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

Secondary Outcome Measures :
  1. Average Energy Intake [ Time Frame: 14 Days ]
  2. Anthropometrics [ Time Frame: 14 Days ]
  3. Medication Use [ Time Frame: 14 days ]


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Ages Eligible for Study:   1 Year to 13 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01191112     History of Changes
Other Study ID Numbers: BK87
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases