Growth and Safety of a Low Lactose Milk-Based Infant Formula

An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants

The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

Inclusion Criteria:

• healthy term infants
• birth weight 2500 - 4500 g
• singleton birth
• 37 - 42 weeks gestation

Exclusion Criteria:

• clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
• receiving medications other than vitamins