An Observational Study of Childhood Food Allergy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Food Hypersensitivity Peanut Hypersensitivity Egg Hypersensitivity Milk Hypersensitivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with food allergy

340 longitudinally followed children with egg and/or milk allergy without elevated peanut specific Immunoglobulin E (IgE), less than 5 kUA/L

No interventions assigned to this group

Full sibling controls for genetic studies

Approximately 250 not age matched full siblings (i.e., non-step siblings, non-half siblings) will be recruited as an additional control group for genetic studies.

No interventions assigned to this group

Full sibling controls for mechanistic studies

Approximately 50 not age matched full siblings (i.e., non-step siblings, non-half siblings) will be recruited as an additional control group for mechanistic studies. A subset of this cohort will be without food allergy,

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Atopic dermatitis evaluation
* Either

1. 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
2. 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
3. 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

* 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

* History of chronic anemia
* Disease or medication that impair immune responses

* Full sibling of child enrolled in study
* Signed informed consent/assent as applicable

Exclusion Criteria

* 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

Minimum Eligible Age

3 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No