Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

Specifically, subjects who have CM allergy will be enrolled. The investigators will perform
an oral food challenge (OFC) to pHWF in each subject. Subjects who pass the challenge will
be placed on pHWF for 2 years. Subjects who do not pass the challenge will receive routine
care. The investigators will perform allergy skin testing, specific IgE measurement, other
serologic assays, and longitudinal OFCs to profile subject characteristics in the two groups
at baseline and over time.

Inclusion Criteria:

- age 0.5-18 years old

- positive skin prick tests (SPT) or detectable serum milk specific IgE and a history
of an allergic reaction to milk within 6 months before study screening; or
milk-specific IgE level or SPT highly predictive for clinical reactivity (if ≤ 2
years old, sIgE >2 kU/L; if > 2 years old, a level >5 kU/L; SPT wheal diameter ≥ 3
mm)

- a clinical reaction during the cows milk oral food challenge

Exclusion Criteria:

- negative SPT and undetectable milk-specific sIgE

- unstable asthma, allergic rhinitis, or atopic dermatitis

- milk-induced eosinophilic gastroenteropathy

- recent reaction to partially hydrolyzed whey formula

- history of severe anaphylaxis with hypotension to cows milk

- participation in any interventional study for the treatment of food allergy in the 6
months prior to screening visit

- inhalant allergent immunotherapy that has not yet reached maintenance dosing

- inability to discontinue antihistamines for skin testing, OFC

- any systemic therapy which in the judgment of the investigator could be
immunomodulatory in the 12 months prior to visit 1 (xolair, rituximab, chronic
steroids, etc)

- investigational drug use 90 days prior to visit 1 or intention to use during study
period

- the presence of any medical condition that the investigator deems incompatible with
participation in the trial.

- unable to understand and speak English