An Observational Study of Childhood Food Allergy

NCT00356174 | Completed DMC

• 1 other identifier: DAIT CoFAR2
• Study Type: observational
• Target: 515
• Locations: 1 country
• Sites: 5

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.

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Egg Hypersensitivity; Milk Hypersensitivity

Keywords

Food Allergy

Outcome Measures

Primary Outcomes (1)

• Peanut allergy after the age of three years

  diagnosed by generally accepted, \> 95% accurate, clinical criteria such as oral food challenge.

  Year 10

Secondary Outcomes (6)

• Resolution of milk allergy after the age of three years

  Year 10

• Resolution of egg allergy after the age of three years

  Year 10

• Resolution of peanut allergy after the age of three years

  Year 10

• Resolution of a positive test to peanut after the age of three years (suspected allergy category)

  Year 10

• Development/persistence of milk allergy after the age of three years

  Year 10

Study Arms (3)

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,

Eligibility Criteria

• Age: 3 Months - 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• History of chronic anemia
• Disease or medication that impair immune responses
• Full sibling of child enrolled in study
• Signed informed consent/assent as applicable

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Consortium of Food Allergy Research: collaborator

Study Sites (5)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (10)

• 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.

  PMID: 15864084 BACKGROUND

• 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.

  PMID: 12417889 BACKGROUND

• 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.

  PMID: 12637607 BACKGROUND

• 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.

  PMID: 11770692 BACKGROUND

• 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.

  PMID: 24636473 RESULT

• 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.

  PMID: 25457149 RESULT

• 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.

  PMID: 23273958 RESULT

• 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.

  PMID: 22732173 RESULT

• 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.

  PMID: 21035177 RESULT

• 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.

  PMID: 20451041 RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swab (DNA)

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Egg Hypersensitivity; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2006
• First Posted: July 25, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (5)