An Observational Study of Childhood Food Allergy

This study is ongoing, but not recruiting participants.
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: April 15, 2015
Last verified: April 2015
  Purpose

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.


Condition
Food Hypersensitivity
Peanut Hypersensitivity
Egg Hypersensitivity
Milk Hypersensitivity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Immune Mechanisms, Genetic Factors, and Clinical and Environmental Characteristics Associated With the Occurrence and Clinical Outcome of Peanut Allergy (CoFAR2)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Peanut allergy after the age of three years [ Time Frame: Year 10 ] [ Designated as safety issue: No ]
    diagnosed by generally accepted, > 95% accurate, clinical criteria such as oral food challenge.


Secondary Outcome Measures:
  • Resolution of milk allergy after the age of three years [ Time Frame: Year 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    determined by well established criteria with > 95% diagnostic accuracy.

  • Resolution of peanut allergy after the age of three years [ Time Frame: Year 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    determined by well established criteria with > 95% diagnostic accuracy.

  • Development/persistence of milk allergy after the age of three years [ Time Frame: Year 10 ] [ Designated as safety issue: Yes ]
    determined by well established criteria with > 95% diagnostic accuracy.

  • Development/persistence of egg allergy [ Time Frame: Year 10 ] [ Designated as safety issue: Yes ]
    determined by well established criteria with > 95% diagnostic accuracy.


Biospecimen Retention:   Samples With DNA

Buccal swab (DNA)


Estimated Enrollment: 640
Study Start Date: July 2006
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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,

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).

  Eligibility

Ages Eligible for Study:   3 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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) 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356174

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Consortium of Food Allergy Research
Investigators
Principal Investigator: Scott Sicherer, MD Jaffe Food Allergy Institute, Mount Sinai School of Medicine
Principal Investigator: Hugh Sampson, MD Pediatric Allergy and Immunology, Mount Sinai School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00356174     History of Changes
Other Study ID Numbers: DAIT CoFAR2
Study First Received: July 21, 2006
Last Updated: April 15, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Food Allergy

Additional relevant MeSH terms:
Egg Hypersensitivity
Food Hypersensitivity
Hypersensitivity
Milk Hypersensitivity
Peanut Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on April 19, 2015