Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants

This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.

Inclusion criteria

• 30 days of age at randomization, inclusive (day of birth is considered day 0)
• Exclusively formula-fed or partially bottle feeding with intake more than 650 ml /day for at least 3 days prior to randomization
• Exclusively breast fed for at least 7 days prior to randomization
• Singleton birth
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks of gestational age)
• Birth weight of 2500g to 4000g
• Signed informed consent obtained for infant's participation in the study
• Parent or guardian of infant agrees not to enroll infant in another interventional clinical research study while participating in this study

Exclusion criteria

• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
• Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
• Participation in another clinical trial
• Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.)
• Having a mother suffering from diabetes during pregnancy
• Use of antibiotics at the time of screening, or during the past two weeks