Extensively Hydrolyzed Formula: Hypoallergenicity

Inclusion criteria

• Born at term (>36 weeks gestation)
• Two (2) months to ≤ 12 years of age at enrollment
• Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:

• Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and [detectable serum milk-specific IgE (>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm]), OR
• Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR
• Results of laboratory tests highly predictive of clinical reactivity to milk

• Serum milk IgE ≥15 [kIU/L]or ≥ 5 [kIU/L if younger than 1 year OR,
• Skin prick tests mean wheal >10 mm
• Otherwise healthy
• If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled
• Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase
• Having obtained his/her legal representative's informed consent.

Exclusion criteria

• Children consuming mother's milk at the time of inclusion and during the trial
• Any chromosomal or major congenital anomalies
• Any major gastrointestinal disease or abnormalities other than CMA
• Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable)
• Immunodeficiency
• Receiving free amino acid formula
• Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable)
• Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay)
• Unstable asthma
• Severe uncontrolled eczema
• Recent ( within the last 3 months) severe anaphylactic reaction to milk
• Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
• Currently participating in another clinical trial