Tolerability and Safety of An Infant Formula

A Multicenter, Single-blind, Randomized, Phase II Study of the Tolerability and Safety of NPS-202 in Infants With Clinically Diagnosed Cow's Milk Allergy

The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.

Inclusion Criteria:

• clinically diagnosed CMA
• </= 12 weeks at time of study entry
• full-term infant
• must be willing to use provided formula as sole source of nutrition
• other than CMA, infant must be otherwise healthy

Exclusion Criteria:

• underlying or confounding gastrointestinal abnormalities
• infants born from an addictive situation, HIV positive
• if parent/guardian is considered likely to be non-compliant with the protocol requirements