Tolerance of Healthy Infants Fed Infant Formulas

Tolerance of Healthy Infants Fed Infant Formulas

The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.

Inclusion Criteria:

• Singleton from a full term birth with a gestational age of 37-42 weeks.
• Birth weight was > 2490 g (~5 lbs 8 oz).
• Age between 0 and 30 days at enrollment.
• Agreement to discontinue the use of medications (including over the counter [OTC], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
• Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
• Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
• Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

• An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Infant treated with antibiotics.
• Participation in another study that has not been approved as a concomitant study by AN.