A Prospective Cohort Study of Immune Mechanisms, Genetic Factors, and Clinical and Environmental Characteristics Associated With the Occurrence and Clinical Outcome of Food Allergy (CoFAR2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 515
- Locations
- 5
- Primary Endpoint
- Peanut allergy after the age of three years
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Months to 15 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Peanut allergy after the age of three years
Time Frame: Year 10
diagnosed by generally accepted, \> 95% accurate, clinical criteria such as oral food challenge.
Secondary Outcomes
- Resolution of peanut allergy after the age of three years(Year 10)
- Resolution of milk allergy after the age of three years(Year 10)
- Resolution of egg allergy after the age of three years(Year 10)
- Resolution of a positive test to peanut after the age of three years (suspected allergy category)(Year 10)
- Development/persistence of milk allergy after the age of three years(Year 10)
- Development/persistence of egg allergy(Year 10)
