Growth and Safety Clinical Trial on a New Infant Formula

Inclusion criteria

• Normal term infant (37-42 weeks gestation at birth)
• Infant <15 (+3) days of age at first study feeding, Birth constitutes day 0
• Infant birth weight of ≥2500 g (5.5 lbs.)
• Healthy Infant
• Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
• Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs)
• Caregiver willing and able to sign informed consent

Exclusion criteria

• Infant born in multiple birth (i.e., twins, triplets, etc.)
• Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
• Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
• Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
• Caregiver intent to feed non-study formula or solid food during the study