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OpenTrials
Completed

NCT Number: NCT02317952

Formula for Children With Cow's Milk Allergy

The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.

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Key information

Conditions

Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

Up to 13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Good health
  • Parent/guardian must be willing to provide informed consent
  • Parent/guardian agrees to feed study formula provided
  • Confirmation of Cow's Milk Allergy

Exclusion criteria

  • No clinically significant abnormal findings on medical history, laboratory results, and physical exam.
  • No medications that may interfere with or impact evaluation of the study assessments
  • Allergy to extensively hydrolyzed casein formula
  • Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit
  • Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention

Treatment and study plan

Experimental Extensively Hydrolyzed Formula

Other

Active Comparator Formula

Other

Primary outcomes

  1. Incidence of Allergic Reaction

    Time frame: 2 weeks

Secondary outcomes

  1. Growth

    Time frame: 16 weeks

    Anthropometric measurements of weight in all enrolled subjects.

  2. Growth

    Time frame: 16 weeks

    Anthropometric measurements of length/height in all enrolled subjects.

Sponsors and collaborators

Lead sponsor

Perrigo Nutritionals

Industry

Registry information

Official study title

A Double-Blind, Randomized, Crossover Allergy Study of an Experimental Formula Followed by a 16 Week Double Blind Feeding Period to Assess Growth, Safety and Development of Tolerance to Cow's Milk Protein

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2014
Registry last updated
Jun 8, 2017

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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