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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)
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.
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).
Age
0 - 1 years
Sex
ALL
Healthy Volunteers
No
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
National Jewish Health
Denver, Colorado, 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
Start Date
July 1, 2006
Primary Completion Date
August 1, 2015
Completion Date
August 1, 2016
Last Updated
September 28, 2016
515
ACTUAL participants
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
NCT04677790
NCT05677074
NCT02350660
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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