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OpenTrials
Completed

NCT Number: NCT01191112

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

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.

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases Feeding Intolerance

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta, Stollery Children's Hospital

Edmonton, Alberta, T6G2J3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peptide based enteral formula

Other

Sole source nutrition as per HCP

Primary outcomes

  1. Stool frequency

    Time frame: 14 Days

  2. Frequency and intensity of irritability, vomiting, distension

    Time frame: 14 Days

Secondary outcomes

  1. Average Energy Intake

    Time frame: 14 Days

  2. Anthropometrics

    Time frame: 14 Days

  3. Medication Use

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2010
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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