An Observational Study of Childhood Food Allergy

September 26, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

515

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Year 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Year 10
Resolution of egg allergy after the age of three years
Time Frame: Year 10
determined by well established criteria with > 95% diagnostic accuracy.
Year 10
Resolution of peanut allergy after the age of three years
Time Frame: Year 10
determined by well established criteria with > 95% diagnostic accuracy.
Year 10
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.
Year 10
Development/persistence of milk allergy after the age of three years
Time Frame: Year 10
determined by well established criteria with > 95% diagnostic accuracy.
Year 10
Development/persistence of egg allergy
Time Frame: Year 10
determined by well established criteria with > 95% diagnostic accuracy.
Year 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Consortium of Food Allergy Research

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 21, 2006

First Submitted That Met QC Criteria

July 21, 2006

First Posted (Estimate)

July 25, 2006

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT CoFAR2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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