Natural History and Genetics of Food Allergy and Related Conditions (NCT02504853) | Clinical Trial Compass
RecruitingNot Applicable
Natural History and Genetics of Food Allergy and Related Conditions
United States1,800 participantsStarted 2015-07-29
Plain-language summary
Background:
\- 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.
Who can participate
Age range1 Day – 99 Years
SexALL
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Inclusion criteria
✓. Be 2 to 99 years-old at the time of enrollment for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years-old at the time of enrollment for participants who will submit mail-in samples or participate in telehealth visits. Only viable neonates will be enrolled.
✓. Willing to allow storage of blood, buccal swabs, saliva, nasal swabs, stool samples, and other clinically appropriate tissue specimens for future use in medical research
✓. Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives
✓. Have a clinical history of an immediate hypersensitivity reaction to food(s) and be sensitized to food allergen(s) (as evidenced by positive SPT or allergen-specific IgE testing)
✓. Be sensitized (as evidenced by positive SPT or allergen-specific IgE testing) to food allergen(s) but have no overt clinical history of IgE-mediated symptoms when they eat that food(s)
✓. 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)
✓. Have a diagnosis of eosinophilic esophagitis (EoE), or clinical suspicion for EoE as determined by the principal investigator (PI) or associate investigators (AIs)
What they're measuring
1
Investigate the key genetic, cellular, immunologic, microbial, and biochemical pathways that lead to the development of food allergy
Timeframe: 06/15/2025
2
Identify biomarkers that predict the clinical course and natural history of patients with food allergy
Timeframe: 06/15/2025
Trial details
NCT IDNCT02504853
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Have a history of atopic dermatitis based on self-report or physician assessment.
Exclusion criteria
✕. uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s. Physical Status Classification System (http://www.asahq.org/resources/clinicalinformation/.asa-physical-status-classification-system)
✕. history of adverse reaction to conscious sedation or general anesthesia required for endoscopy
✕. hemoglobin \< 11 g/dL
✕. platelet count \< 100,000 microL
✕. PT INR \>1.3 or PTT prolonged by \> 3 seconds
✕. pregnant or breastfeeding
✕. viral screens positive for HIV or hepatitis B or C
✕. severe unstable myocardial ischemia or cardiomyopathy