Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula

This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96

Inclusion criteria

• Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days)
• Birth weight of ≥ 2,500 g and ≤ 4,500 g
• Postnatal age ≤ 11 days at time of enrollment
• Singleton
• 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, reporting of AEs, and urine collection)
• Caregiver willing and able to sign IRB approved informed consent

Exclusion criteria

• Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
• 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
• Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin)
• Infant receiving prescription medication
• Infant with a known history of cow's milk protein allergy, excluding lactose intolerance
• Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development
• Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder
• Caregiver intent to feed non-study formula or solid food during the study