ORAL IMMUNOTHERAPY FOR COW'S MILK ALLERGY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. BACKGROUND: Cow's milk allergy (CMA) is the most common food allergy in infants and young children, affecting 2-3% of the general population. The current management of milk allergy is to avoid all forms of milk until the body naturally develops tolerance. Although previous prospective studies show a good prognosis, with up to 85% of children outgrowing their allergy by age 3, we see an increasing number of children whose CMA persists into school age and beyond. For these children, an alternative to milk avoidance, which carries it's own risks, would be ideal. RATIONALE: Subcutaneous immunotherapy ("allergy shots") has a long record of use for treatment of environmental allergies. It appears that this type of immunotherapy for foods has an unacceptably high rate of side effects. Initial studies using orally administered immunotherapy for food allergies appears safer and potentially effective. STUDY QUESTION: Can oral immunotherapy for milk allergy be safe and effective in reducing or eliminating sensitivity to cow's milk protein in milk-allergic individuals? DESIGN: This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited at 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Blood-work, skin prick tests (SPTs), and pulmonary function tests (PFTs), will be done initially and at periodic intervals. STUDY POPULATION: Children between the ages of 6 and 21 years with a history of symptomatic allergy to milk and a positive blood or skin test to milk will be considered for enrollment. OUTCOME MEASURES: Primary: The percentage of patients who can tolerate four times the initial OFC threshold dose or the maximum OFC dose of 8 grams after therapy. Secondary: o Incidence of protocol-defined severe hypersensitivity reactions during the study o Incidence of all serious adverse events during the study o Incidence of all adverse events o To assess for any changes in milk-IgE, m-IgG4, and total IgE during OIT and as milk allergy persists or resolves.