NCT02317952
Completed
Not Applicable
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
ConditionsMilk Allergy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Milk Allergy
- Sponsor
- Perrigo Nutritionals
- Enrollment
- 90
- Locations
- 18
- Primary Endpoint
- Incidence of Allergic Reaction
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of Allergic Reaction
Time Frame: 2 weeks
Secondary Outcomes
- Growth(16 weeks)
Study Sites (18)
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