A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Inclusion Criteria: * Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable * Age 6 to 21 years * Must have history of symptomatic reactivity to cow's milk (eczema, urticaria, upper/lower resp., GI, other associated rash, oral symptoms) * History of positive skin prick test (wheal \>/= histamine control) or milk-Immunoglobulin E (IgE)\>0.35 kilounits per liter (kU/L) * Positive DBPCFC * All females of child bearing age must be using appropriate birth control Exclusion Criteria: * History of anaphylaxis requiring hospitalization * History of intubation related to asthma * Has the ability to tolerate \>2.4gram of milk protein at initial DBPCFC * Has a history of allergy to any component of vehicle * Pregnancy (need negative test) * Viral upper respiratory infection (URI) or gastroenteritis within 7days of OFC (OFC needs to be rescheduled) * Has pulmonary function tests \<80% of predicted (FEV1) or clinical history consistent with moderate persistent asthma * Currently taking greater than medium dose inhaled corticosteroid (\>400mcg/day fluticasone or fluticasone equivalent if \</=12yo or \>600mcg/day if \>12 years old) * Antihistamine within 1 week prior to skin testing or food challenges (Skin testing and/or food challenge needs to be rescheduled) * Systemic corticosteroid within 4 weeks prior to baseline visit * Receiving omalizumab, beta-blocker, Angiotensin-converting enzyme (ACE) inhibitor or tricyclic antidepressant therapy * Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes) * Participation in any interventional study for treatment of a food allergy in the past 12 months * Severe reaction at initial DBPCFC, defined as: i. Life-threatening anaphylaxis ii. Requires overnight hospitalization