Formula for Children With Cow's Milk Allergy

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

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

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