ClinicalTrials.gov record NCT02504853

Natural History and Genetics of Food Allergy and Related Conditions

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Natural History and Genetics of Food Allergy and Related Conditions

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
AgeUnder 1 month old to 99 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study that follows people with food allergy and related conditions, their relatives, and unrelated healthy volunteers. Participants provide medical history, questionnaires, and biological samples and will have at least three visits over 1–2 years with annual follow-up for many years. Some procedures (for example leukapheresis and endoscopy with biopsies) have extra age and health requirements (leukapheresis requires age ≥18 and stable blood counts; endoscopy/biopsy has additional health and pregnancy-related restrictions).

What it is studying. The study aims to learn which genetic, cellular, immunologic, microbial, and biochemical pathways are linked to food allergy and to find biomarkers that help predict the clinical course and natural history of these conditions.

What the researchers hope to learn. Investigate genetic, cellular, immunologic, microbial, and biochemical pathways that lead to food allergy; identify biomarkers that predict clinical course and natural history; estimate prevalence of eosinophilic gastrointestinal disease in high-risk groups; enable in vitro testing of candidate therapies on patient-derived cells; identify nutritional deficiencies and their effects on growth and health in affected patients.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • GENERAL INCLUSION CRITERIA:
  • All participants must meet the following 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
  • ADDITIONAL INCLUSION CRITERIA FOR AFFECTED PARTICIPANTS
  • In addition to the general criteria listed above, affected participants must meet 1 of the following criteria:
  • 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)
  • Have a history of atopic dermatitis based on self-report or physician assessment.
  • ADDITIONAL INCLUSION CRITERIA FOR UNAFFECTED RELATIVES:
  • In addition to the general criteria listed above, unaffected relatives must meet the following criteria:
  • Be a relative of an affected participant
  • Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study
  • ADDITIONAL INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS
  • In addition to the general criteria listed above, healthy volunteers must meet the following criteria:
  • Be unrelated to an affected participant
  • Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study
  • ADDITIONAL PROCEDURE- SPECIFIC INCLUSION CRITERIA:
  • The following additional inclusion criteria apply for participants undergoing leukapheresis:
  • Age >= 18 years
  • Stable hematologic parameters (definition: white blood cell count > 2,500/microL, hemoglobin > 10 g/dL, and platelet count > 75,000/microL)
  • GENERAL

Exclusion criteria

  • Participants will be excluded for any of the following:
  • Presence of conditions that, in the judgment of the investigator or the referring physician, may put the participant at undue risk or make them unsuitable for participation in the study.
  • Inability to participate for the duration of the study.
  • The PI deems that participation in the study would not be expected to advance the study goals.
  • ADDITIONAL PROCEDURE- SPECIFIC EXCLUSION CRITERIA
  • Additional exclusion criteria apply for unaffected relatives and healthy volunteers who are undergoing endoscopy with biopsies for research purposes. Unaffected relatives and healthy volunteers will be excluded from participating in this procedure if they meet any of the following criteria:
  • uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s Physical Status Classification System (https://journals.lww.com/anesthesiologyopen/fulltext/2026/04000/american_society_of_anesthesiologists_statement_on.2.aspx)
  • 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
  • severe hypoxemia due to chronic pulmonary disease
  • recent abdominal surgery
  • anticoagulant therapy that cannot be interrupted
  • history of reflux disease within the last 3 years or use of acid-suppression medication (including over-the-counter medications such as Tums, Rolaids, Zantac, Prilosec OTC, or Prevacid OTC) within the last 2 months
  • chronic GI or immunologic disease
  • clinically indicated EGD or colonoscopy within the past 12 months
  • use of systemic or inhaled corticosteroids within the past 4 months
  • have a history of EGID including EoE
  • younger than 18 years of age

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have screening (medical history, physical exam, questionnaires) and at least three visits over 1–2 years, then yearly follow-up (many participants up to 12 years; some with identified genetic/congenital disorders or a subset of food‑allergy participants may be followed up to 25 years). Procedures can include blood tests and allergy skin‑prick testing; collection and storage of blood, saliva, stool, swabs, skin samples, and photographs; and sample‑collection methods such as tape‑stripping and cheek or nasal swabs. Some participants may undergo more invasive procedures such as leukapheresis, tiny skin biopsies, an esophageal string test, and endoscopy (EGD) with biopsies or colonoscopy. Some visits or sample collection may be done by mail‑in kits or telehealth for eligible participants.

How the study is structured. Prospective, observational (case-control) study. Participants include affected people, their unaffected relatives, and unrelated healthy volunteers. Visits include medical history and physical exam, questionnaires, regular follow-up, and collection of biological samples (blood, saliva, stool, skin and mucosal swabs). Depending on the participant, procedures may include allergy skin-prick testing, leukapheresis (adults), the esophageal string test, endoscopy with biopsies, skin biopsies or tape strips, and photographs. Some procedures are optional or limited by additional age/health requirements.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Jul 29, 2015
Primary completion
Jun 15, 2027 (estimated)
Study completion
Jun 15, 2027 (estimated)
Target enrollment
1800 participants (estimated)
Last updated on registry
Oct 2, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

INCLUSION CRITERIA
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
principal investigator
The doctor or scientist responsible for running the study at a site or overall.
EXCLUSION CRITERIA
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
natural history
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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