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

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