Actively Recruiting
Natural History and Genetics of Food Allergy and Related Conditions
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-01
1800
Participants Needed
1
Research Sites
567 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Natural History and Genetics of Food Allergy and Related Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 2 and 99 years old at enrollment for in-person visits, or 0 to 99 years old for mail-in samples or telehealth (only viable newborns).
- Willing to allow storage of blood, swabs, saliva, stool, and other tissue samples for future research.
- Have a primary care or other physician managing all health conditions.
- For affected participants: have a clinical history of immediate hypersensitivity to foods with positive allergy tests, or be sensitized to food allergens without symptoms, or have a suspected genetic or congenital disorder related to food allergy, or have eosinophilic esophagitis or suspicion of it, or have atopic dermatitis.
- For unaffected relatives: be related to an affected participant and be unaffected by food allergy or the genetic condition.
- For healthy volunteers: be unrelated to affected participants and unaffected by food allergy or genetic conditions.
- For leukapheresis procedure: be 18 years or older with stable blood counts (WBC > 2,500/microL, hemoglobin > 10 g/dL, platelet count > 75,000/microL).
You will not qualify if you...
- Conditions that pose undue risk or make participation unsuitable as judged by investigators.
- Inability to participate for the study duration.
- Participation unlikely to advance study goals.
- For unaffected relatives and healthy volunteers undergoing endoscopy: uncontrolled asthma or ASA physical status Grade 3 or higher.
- History of adverse reaction to sedation or anesthesia.
- Hemoglobin less than 11 g/dL.
- Platelet count less than 100,000/microL.
- Prolonged clotting times (PT INR >1.3 or PTT prolonged by >3 seconds).
- Pregnant or breastfeeding.
- Positive viral screens for HIV or hepatitis B or C.
- Severe unstable heart or lung disease.
- Recent abdominal surgery.
- Anticoagulant therapy that cannot be stopped.
- History of reflux disease in last 3 years or recent use of acid-suppression medication.
- Chronic gastrointestinal or immune disease.
- Clinically indicated endoscopy within past 12 months.
- Use of systemic or inhaled corticosteroids within past 4 months.
- History of eosinophilic gastrointestinal disorders including eosinophilic esophagitis.
- Younger than 18 years old for endoscopy procedures.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
E
Ellen Zektser, R.N.
CONTACT
P
Pamela A Guerrerio, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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