An Observational Study of Childhood Food Allergy

Tracking Information
First Submitted Date	July 21, 2006
First Posted Date	July 25, 2006
Last Update Posted Date	September 28, 2016
Study Start Date	July 2006
Actual Primary Completion Date	August 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 15, 2015)	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.
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00356174 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: April 15, 2015)	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.; Resolution of egg allergy after the age of three years [ Time Frame: Year 10 ]determined by well established criteria with > 95% diagnostic accuracy.; Resolution of peanut allergy after the age of three years [ Time Frame: Year 10 ]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 ]determined by well established criteria with > 95% diagnostic accuracy.; Development/persistence of milk allergy after the age of three years [ Time Frame: Year 10 ]determined by well established criteria with > 95% diagnostic accuracy.; Development/persistence of egg allergy [ Time Frame: Year 10 ]determined by well established criteria with > 95% diagnostic accuracy.
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	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)
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).
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Buccal swab (DNA)
Sampling Method	Non-Probability Sample
Study Population	Children with milk or egg allergy who are at risk for peanut allergy
Condition	Food Hypersensitivity; Peanut Hypersensitivity; Egg Hypersensitivity; Milk Hypersensitivity
Intervention	Not Provided
Study 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,
Publications *	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.; 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.; 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.; 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.; 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.; 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.; 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.; 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.; 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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: May 12, 2015)	515
Original Enrollment; (submitted: July 21, 2006)	650
Actual Study Completion Date	August 2016
Actual Primary Completion Date	August 2015 (Final data collection date for primary outcome measure)
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 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 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 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
Sex/Gender	Sexes Eligible for Study: All
Ages	3 Months to 15 Months (Child)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00356174
Other Study ID Numbers	DAIT CoFAR2
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Institute of Allergy and Infectious Diseases (NIAID)
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
PRS Account	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	September 2016