Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

This is an interventional diagnostic trial for Food Allergy focused on measuring Food Allergy, Cows Milk Allergy Read More

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