An Observational Study of Childhood Food Allergy

Food Hypersensitivity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356174
• Other study ID #: DAIT CoFAR2
• Status: Completed
• Phase: N/A
• First received: July 21, 2006
• Last updated: September 26, 2016
• Start date: July 2006
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 15 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Egg Hypersensitivity
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity
• Peanut Hypersensitivity

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of North Carolina	Chapel Hill	North Carolina
United States	National Jewish Health	Denver	Colorado
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Consortium of Food Allergy Research

Country where clinical trial is conducted

United States, 

References & Publications (10)

Björkstén B. Genetic and environmental risk factors for the development of food allergy. Curr Opin Allergy Clin Immunol. 2005 Jun;5(3):249-53. Review. — View 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 pe — View 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. d — View 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. — View 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. Epub 2003 Mar 10. — View Citation

Sicherer SH, Noone SA, Muñoz-Furlong A. The impact of childhood food allergy on quality of life. Ann Allergy Asthma Immunol. 2001 Dec;87(6):461-4. — View 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 — View 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 — View 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. — View 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: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peanut allergy after the age of three years	diagnosed by generally accepted, > 95% accurate, clinical criteria such as oral food challenge.	Year 10	No
Secondary	Resolution of milk allergy after the age of three years	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	No
Secondary	Resolution of egg allergy after the age of three years	determined by well established criteria with > 95% diagnostic accuracy.	Year 10	No
Secondary	Resolution of peanut allergy after the age of three years	determined by well established criteria with > 95% diagnostic accuracy.	Year 10	No
Secondary	Resolution of a positive test to peanut after the age of three years (suspected allergy category)	determined by well established criteria with > 95% diagnostic accuracy.	Year 10	No
Secondary	Development/persistence of milk allergy after the age of three years	determined by well established criteria with > 95% diagnostic accuracy.	Year 10	Yes
Secondary	Development/persistence of egg allergy	determined by well established criteria with > 95% diagnostic accuracy.	Year 10	Yes

External Links

•   Consortium of Food Allergy Research (CoFAR)
•   National Institute of Allergy and Infectious Diseases (NIAID)