Status:
COMPLETED
An Observational Study of Childhood Food Allergy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Consortium of Food Allergy Research
Conditions:
Food Hypersensitivity
Peanut Hypersensitivity
Eligibility:
All Genders
3-15 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Children with Food Allergy: Participants who meet all of the following criteria are eligible for enrollment as study participants:
- Atopic dermatitis evaluation
- Either
- A convincing clinical history of cow's milk (and/or egg) allergy and a positive prick skin test (≥ 3mm larger than the negative control) to cow's milk (and/or egg, if egg allergy history), or
- Moderate to severe atopic dermatitis at the time of enrollment (or by a history prior to removal of milk and/or egg from the maternal (if breastfed) or infant diet) and a positive prick skin test to milk or egg, or
- Positive oral food challenge, prior to study entry, to either milk or egg with positive skin test
- Written informed consent from parent/guardian
- Willing to submit specimen for central laboratory plasma peanut IgE
- Exclusion Criteria for Children with Food Allergy:
- Participants who meet any of these criteria are not eligible for enrollment as study participants:
- Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Participation in an interventional study\*
- Inability to discontinue antihistamines for routine tests
- Children (other than sibling controls) from families with one child already participating in the observational study
- Confirmed or convincing evidence of peanut allergy
- Sibling Inclusion Criteria for Mechanistic Studies:
- No history of food allergy (unrestricted diet), asthma, atopic dermatitis, allergic rhinitis (for blood sample)
- Full sibling of child enrolled in study
- Signed informed consent/assent as applicable
- Sibling Exclusion Criteria in Mechanistic Studies:
- Not fulfilling inclusion criteria
- History of chronic anemia
- Disease or medication that impair immune responses
- Sibling Inclusion Criteria for Genetic Testing:
- Full sibling of child enrolled in study
- Signed informed consent/assent as applicable
- Sibling Exclusion Criteria for Genetic Testing:
- Not fulfilling inclusion criteria
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT00356174
Start Date
July 1 2006
End Date
August 1 2016
Last Update
September 28 2016
Active Locations (5)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
National Jewish Health
Denver, Colorado, United States, 80206
3
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029