Clinical trial NCT00356174: An Observational Study of Childhood Food Allergy
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Hypersensitivity
Peanut Hypersensitivity
Egg Hypersensitivity
Milk Hypersensitivity
Keywords: Food Allergy
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Consortium of Food Allergy Research
First posted: 2006-07-25
Enrollment: 515
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with milk or egg allergy who are at risk for peanut allergy

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).

Eligibility 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 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

Primary outcomes:
measure: Peanut allergy after the age of three years
timeFrame: Year 10
Secondary outcomes:
measure: Resolution of milk allergy after the age of three years
timeFrame: Year 10
measure: Resolution of egg allergy after the age of three years
timeFrame: Year 10
measure: Resolution of peanut allergy after the age of three years
timeFrame: Year 10
measure: Resolution of a positive test to peanut after the age of three years (suspected allergy category)
timeFrame: Year 10
measure: Development/persistence of milk allergy after the age of three years
timeFrame: Year 10
measure: Development/persistence of egg allergy
timeFrame: Year 10
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Jaffe Food Allergy Institute, Icahn School of at Mount Sinai
name: Scott Sicherer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Allergy and Immunology, Icahn School of at Mount Sinai
name: Hugh Sampson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjorksten B. Genetic and environmental risk factors for the development of food allergy. Curr Opin Allergy Clin Immunol. 2005 Jun;5(3):249-53. doi: 10.1097/01.all.0000168790.82206.17.
citation: Grundy J, Matthews S, Bateman B, Dean T, Arshad SH. Rising prevalence of allergy to peanut in children: Data from 2 sequential cohorts. J Allergy Clin Immunol. 2002 Nov;110(5):784-9. doi: 10.1067/mai.2002.128802.
citation: Lack G, Fox D, Northstone K, Golding J; Avon Longitudinal Study of Parents and Children Study Team. Factors associated with the development of peanut allergy in childhood. N Engl J Med. 2003 Mar 13;348(11):977-85. doi: 10.1056/NEJMoa013536. Epub 2003 Mar 10.
citation: Sicherer SH, Noone SA, Munoz-Furlong A. The impact of childhood food allergy on quality of life. Ann Allergy Asthma Immunol. 2001 Dec;87(6):461-4. doi: 10.1016/S1081-1206(10)62258-2.
citation: Sicherer SH, Wood RA, Vickery BP, Jones SM, Liu AH, Fleischer DM, Dawson P, Mayer L, Burks AW, Grishin A, Stablein D, Sampson HA. The natural history of egg allergy in an observational cohort. J Allergy Clin Immunol. 2014 Feb;133(2):492-9. doi: 10.1016/j.jaci.2013.12.1041.
citation: Brough HA, Liu AH, Sicherer S, Makinson K, Douiri A, Brown SJ, Stephens AC, Irwin McLean WH, Turcanu V, Wood RA, Jones SM, Burks W, Dawson P, Stablein D, Sampson H, Lack G. Atopic dermatitis increases the effect of exposure to peanut antigen in dust on peanut sensitization and likely peanut allergy. J Allergy Clin Immunol. 2015 Jan;135(1):164-70. doi: 10.1016/j.jaci.2014.10.007. Epub 2014 Nov 18.
citation: Wood RA, Sicherer SH, Vickery BP, Jones SM, Liu AH, Fleischer DM, Henning AK, Mayer L, Burks AW, Grishin A, Stablein D, Sampson HA. The natural history of milk allergy in an observational cohort. J Allergy Clin Immunol. 2013 Mar;131(3):805-12. doi: 10.1016/j.jaci.2012.10.060. Epub 2012 Dec 28.
citation: Fleischer DM, Perry TT, Atkins D, Wood RA, Burks AW, Jones SM, Henning AK, Stablein D, Sampson HA, Sicherer SH. Allergic reactions to foods in preschool-aged children in a prospective observational food allergy study. Pediatrics. 2012 Jul;130(1):e25-32. doi: 10.1542/peds.2011-1762. Epub 2012 Jun 25.
citation: Sicherer SH, Wood RA, Stablein D, Lindblad R, Burks AW, Liu AH, Jones SM, Fleischer DM, Leung DY, Sampson HA. Maternal consumption of peanut during pregnancy is associated with peanut sensitization in atopic infants. J Allergy Clin Immunol. 2010 Dec;126(6):1191-7. doi: 10.1016/j.jaci.2010.08.036. Epub 2010 Oct 28.
citation: Sicherer SH, Wood RA, Stablein D, Burks AW, Liu AH, Jones SM, Fleischer DM, Leung DY, Grishin A, Mayer L, Shreffler W, Lindblad R, Sampson HA. Immunologic features of infants with milk or egg allergy enrolled in an observational study (Consortium of Food Allergy Research) of food allergy. J Allergy Clin Immunol. 2010 May;125(5):1077-1083.e8. doi: 10.1016/j.jaci.2010.02.038.