Milk Allergy
Conditions
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.
Interventions
OTHERActive Comparator Formula
Sponsors
Perrigo Nutritionals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Allergic Reaction | 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth | 16 weeks | Anthropometric measurements of weight in all enrolled subjects. |
Countries
United States
Outcome results
None listed