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: May 12, 2015
Last verified: May 2015

July 21, 2006
May 12, 2015
July 2006
July 2015   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00356174 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
An Observational Study of Childhood Food Allergy
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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Buccal swab (DNA)

Non-Probability Sample

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

  • Food Hypersensitivity
  • Peanut Hypersensitivity
  • Egg Hypersensitivity
  • Milk Hypersensitivity
Not Provided
  • 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,

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
515
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
3 Months to 15 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00356174
DAIT CoFAR2
No
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Consortium of Food Allergy Research
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
National Institute of Allergy and Infectious Diseases (NIAID)
May 2015

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