Infant Formula in Infants and Children With Cow's Milk Allergy

Inclusion Criteria10

• Participant's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
• Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE \>0.7 kUᴀ/L or positive skin prick test wheal ≥5 mm;
• Documentation of milk-specific serum IgE \>15 kUᴀ/L or \> 5 kUᴀ/L if younger than 1 year;
• Documented cow's milk skin prick test wheal \>10mm;
• Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
• Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges.
• Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment.
• Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
• Participant is between 3 months and 12 years of age at enrollment.
• Participant's parent(s) has 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.