Natural History and Genetics of Food Allergy and Related Conditions
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|ClinicalTrials.gov Identifier: NCT02504853|
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : September 8, 2022
- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them.
- To learn more about the causes and effects of food allergy and related conditions.
- People ages 2 99 who have food allergy and/or a related genetic or other condition
- Their relatives
- Healthy relatives and volunteers
- Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer.
- Participants will be screened with medical history, physical exam, and questionnaires.
- Participants may have the following:
- Blood tests
- Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop.
- Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm.
- Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour.
- EGD and colonoscopy: Biopsies are taken from the gastrointestinal system.
- Tiny biopsies of skin
- Photographs of the body
- Collection of cells through:
- Swab of nose, inside of cheek, or skin
- Gentle skin scrape
- Tape stripping: piece of tape is put on the skin and pulled off.
|Condition or disease|
|Food Allergy Loeys-Dietz Syndrome Atopic Dermatitis Eosinophilic Esophagitis|
There are approximately 15 million Americans, including 6 million children, who have a potentially life-threatening food allergy. The prevalence of this disease has increased over the last three decades, in both the United States and other developed countries. There are no cures or effective prevention or treatment strategies for food allergy. Moreover, little is known about the factors that account for the rising prevalence and severity of these diseases in recent years. Both genetic and environmental factors likely contribute to the development of food allergy, but the complex interaction between these variables has frustrated efforts to elucidate pathogenesis and develop mechanism-targeted therapies. Children with food allergy are 2 to 4 times more likely to be diagnosed with asthma or other allergic conditions than children without food allergy, and food allergy may also be an important trigger for atopic dermatitis and eosinophilic esophagitis. The Laboratory of Allergic Diseases within the National Institute of Allergy and Infectious Diseases has a longstanding interest in the genetics and pathogenesis of allergic inflammatory disorders, and with the National Institutes of Health Clinical Center, it provides the ideal environment for the proposed translational studies. In this study, we will: (1) investigate the key genetic, cellular, immunologic, and biochemical pathways that lead to the development of food allergy, and (2) identify biomarkers that predict the clinical course and natural history of patients with food allergy.
Subjects eligible for enrollment in this study include children and adults with food allergy and patients with a known/suspected genetic or congenital disorder potentially associated with these phenotypes. Unaffected relatives (children and adults) of an enrolled subject and healthy volunteers (children and adults) will also be eligible for enrollment as controls. Most participants will be followed for 2 years, although participants with an identified genetic or congenital disorder and a subset of participants with food allergy may be followed until this study ends (up to 25 years).
Data obtained from analysis of blood, skin, saliva, stool, gastrointestinal biopsies, and other specimens will be used to explore the immunologic, biochemical, microbial, and genetic basis of food allergy. Results of research studies will be correlated with the scope and severity of their clinical phenotype, their response to treatment, and the natural history of their allergic disease(s).
|Study Type :||Observational|
|Estimated Enrollment :||950 participants|
|Official Title:||Natural History and Genetics of Food Allergy and Related Conditions|
|Actual Study Start Date :||July 29, 2015|
|Estimated Primary Completion Date :||June 15, 2025|
|Estimated Study Completion Date :||June 15, 2025|
Have a suspected genetic or congenital disorder potentially associated with food allergy or related condition, as determined by the principal investigator (PI) or associate investigators (AIs).
Affected Non-Syndromic Food
Individuals with a clinical history of immediate hypersensitivity reaction to foods and sensitized to food allergen(s) as evidenced by SPT or allergen-specific IgE testing.
Allergic GI Disease
Individuals with a diagnosis or clinical suspicion of eosinophilic esophagitis (EoE), as determined by the principal investigator (PI) or associate investigators (AIs).
Unaffected Relative/Healthy Volunteer
Unaffected relatives are relatives of affected; unaffected by food allergy or the genetic condition under study. Healthy volunteers are not related to affected and serve as controls.
- Investigate the key genetic, cellular, immunologic, microbial, and biochemical pathways that lead to the development of food allergy [ Time Frame: 06/15/2025 ]Investigate the key genetic, cellular, immunologic, microbial, and biochemical pathways that lead to the development of food allergy
- Identify biomarkers that predict the clinical course and natural history of patients with food allergy [ Time Frame: 06/15/2025 ]Identify biomarkers that predict the clinical course and natural history of patients with food allergy
- The prevalence of eosinophilic GI disease in patients who might be considered to be at high risk for these conditions, including those patients with atopic dermatitis and/or multiple food sensitivities/allergies [ Time Frame: 06/15/2025 ]
- In vitro testing of novel therapies for food allergy using cells and other biological specimens obtained from patients with food allergy [ Time Frame: 06/15/2025 ]
- Identification of nutritional deficiencies and their effect on the growth and overall health of patients with food allergy and related conditions [ Time Frame: 06/15/2025 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504853
|Contact: Ellen Zekster, R.N.||Not Listedfirstname.lastname@example.org|
|Contact: Pamela A Guerrerio, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Pamela A Guerrerio, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|