Natural History and Genetics of Food Allergy and Related Conditions
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- STATUS
- Recruiting
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- End date
- Jun 15, 2025
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- participants needed
- 950
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- sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Summary
- Background
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- 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.
- Objective
- To learn more about the causes and effects of food allergy and related conditions.
- Eligibility
- People ages 2 99 who have food allergy and/or a related genetic or other condition
- Their relatives
- Healthy relatives and volunteers
- Design
- 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.
- X-rays
- 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.
- 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.
Description
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).
Details
| Condition | Food Allergy, Loeys-Dietz Syndrome, Atopic Dermatitis, Eosinophilic Esophagitis |
|---|---|
| Clinical Study Identifier | NCT02504853 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Last Modified on | 18 June 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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