An Observational Study of Childhood Food Allergy

This study has been completed.

Sponsor:

Collaborator:

Consortium of Food Allergy Research

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00356174

First received: July 21, 2006

Last updated: September 26, 2016

Last verified: September 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2006

Last Updated Date

September 26, 2016

Start Date ^ICMJE

July 2006

Primary Completion Date

August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00356174 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Observational Study of Childhood Food Allergy

Official Title ^ICMJE

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 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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Buccal swab (DNA)

Sampling Method

Non-Probability Sample

Study Population

Children with milk or egg allergy who are at risk for peanut allergy

Condition ^ICMJE

Food Hypersensitivity
Peanut Hypersensitivity
Egg Hypersensitivity
Milk Hypersensitivity

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

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
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.
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,

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

515

Completion Date

August 2016

Primary Completion Date

August 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
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

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

3 Months to 15 Months (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00356174

Other Study ID Numbers ^ICMJE

DAIT CoFAR2

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

National Institute of Allergy and Infectious Diseases (NIAID)

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Consortium of Food Allergy Research

Investigators ^ICMJE

Principal Investigator:	Scott Sicherer, MD	Jaffe Food Allergy Institute, Icahn School of at Mount Sinai
Principal Investigator:	Hugh Sampson, MD	Pediatric Allergy and Immunology, Icahn School of at Mount Sinai

PRS Account

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

September 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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