An Observational Study of Childhood Food Allergy
- Conditions
- Peanut HypersensitivityEgg HypersensitivityFood HypersensitivityMilk Hypersensitivity
- Registration Number
- NCT00356174
- Brief Summary
The purpose of this study is to observe the natural course of food allergy, including both the development of peanut allergy in infants at high risk for developing this allergy, and the resolution of both egg and cow's milk allergy.
- Detailed Description
This observational study will investigate the developmental immunology of peanut, egg, and milk allergy in a cohort of milk- or egg-allergic children who are at risk for peanut allergy. This strategy will help to delineate, compare, and contrast biological markers and immunologic changes associated with the development of peanut allergy and loss of egg and milk allergy, while simultaneously evaluating important clinical and environmental influences likely to account for the recent rise in the prevalence of these allergies. The hallmark of food-allergic disease is the production of food-specific Immunoglobulin E (IgE) antibodies that represent an end result of a T helper 2 (Th2) influenced immune response. Currently, there is only a limited understanding of the mechanisms involved in the developmental course of food allergies. To effectively prevent or reverse the progression of food allergy, immune interventions will be needed. Furthermore, it is likely that successful strategies will need to be directed to those persons at identifiable risk (e.g., who have biomarkers associated with development of peanut allergy).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 515
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peanut allergy after the age of three years Year 10 diagnosed by generally accepted, \> 95% accurate, clinical criteria such as oral food challenge.
- Secondary Outcome Measures
Name Time Method Resolution of peanut allergy after the age of three years Year 10 determined by well established criteria with \> 95% diagnostic accuracy.
Resolution of milk allergy after the age of three years Year 10 determined by well established criteria with \> 95% diagnostic accuracy. Additional (interval analysis) endpoints of egg and milk allergy will be explored in younger children because these allergies may resolve earlier. Common clinical allergy evaluations (e.g., prick skin tests and food-specific IgE antibodies to the 3 targeted foods and common environmental allergens) will be performed and incorporated in the diagnoses of food allergy and atopy.
Resolution of egg allergy after the age of three years Year 10 determined by well established criteria with \> 95% diagnostic accuracy.
Resolution of a positive test to peanut after the age of three years (suspected allergy category) Year 10 determined by well established criteria with \> 95% diagnostic accuracy.
Development/persistence of milk allergy after the age of three years Year 10 determined by well established criteria with \> 95% diagnostic accuracy.
Development/persistence of egg allergy Year 10 determined by well established criteria with \> 95% diagnostic accuracy.
Trial Locations
- Locations (5)
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States