Clinical Trial: An Observational Study of Childhood Food Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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)

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 Summary: 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).
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • Resolution of milk allergy after the age of three years [ Time Frame: 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 [ Time Frame: Year 10 ]
    determined by well established criteria with > 95% diagnostic accuracy.
  • Resolution of peanut allergy after the age of three years [ Time Frame: 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) [ Time Frame: Year 10 ]
    determined by well established criteria with > 95% diagnostic accuracy.
  • Development/persistence of milk allergy after the age of three years [ Time Frame: Year 10 ]
    determined by well established criteria with > 95% diagnostic accuracy.
  • Development/persistence of egg allergy [ Time Frame: Year 10 ]
    determined by well established criteria with > 95% diagnostic accuracy.


Original Secondary Outcome:

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: July 21, 2006
Date Started: July 2006
Date Completion:
Last Updated: September 26, 2016
Last Verified: September 2016