Skip to main content
Clinical Trials/NCT00356174
NCT00356174CompletedNot Applicable

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)

National Institute of Allergy and Infectious Diseases (NIAID)5 sites in 1 country515 target enrollmentStarted: July 2006Last updated:
Conditions

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)

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (5)

Loading locations...

Similar Trials