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Food HypersensitivityNCT00356174

An Observational Study of Childhood Food Allergy

An observational study of Food Hypersensitivity and Peanut Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 15 months
How many people
515 participants
Where
5 sitesUnited States
Study dates
Jul 2006to Aug 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 15 months
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • National Jewish Health

    Denver, Colorado, 80206

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

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)

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.

Read the 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).

Keywords
Food Allergy
Medical subject headings
Food Hypersensitivity, Peanut Hypersensitivity, Egg Hypersensitivity, Milk Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00356174
Study groupRoleWhat they receive
Children with food allergy340 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 studiesApproximately 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 studiesApproximately 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,

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peanut allergy after the age of three years

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

    Measured: Year 10

Secondary outcomes (6)

  1. 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.

    Measured: Year 10

  2. Resolution of egg allergy after the age of three years

    determined by well established criteria with > 95% diagnostic accuracy.

    Measured: Year 10

  3. Resolution of peanut allergy after the age of three years

    determined by well established criteria with > 95% diagnostic accuracy.

    Measured: Year 10

  4. 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.

    Measured: Year 10

  5. Development/persistence of milk allergy after the age of three years

    determined by well established criteria with > 95% diagnostic accuracy.

    Measured: Year 10

  6. Development/persistence of egg allergy

    determined by well established criteria with > 95% diagnostic accuracy.

    Measured: Year 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionAug 2015
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00356174
Sponsor's protocol ID
DAIT CoFAR2
Status last verified
Sep 2016
First submitted
21 Jul 2006
Last updated
28 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15864084

  • 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.

    PubMed 12417889

  • 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.

    PubMed 12637607

  • 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.

    PubMed 11770692

  • 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.

    PubMed 24636473

  • 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.

    PubMed 25457149

  • 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.

    PubMed 23273958

  • 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.

    PubMed 22732173

  • 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.

    PubMed 21035177

  • 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.

    PubMed 20451041

Questions about this trial

What is this clinical trial studying?

An observational study of Food Hypersensitivity and Peanut Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peanut allergy after the age of three years (time frame: Year 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356174, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.

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