Natural History and Genetics of Food Allergy and Related Conditions

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT02504853
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 99 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jul 29, 2015
Status verified
May 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
1,800 participants (estimated)

Arms

  • Arm: Affected Genetic
    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).
  • Arm: 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.
  • Arm: 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).
  • Arm: 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.

Primary Outcome Measure

Investigate the key genetic, cellular, immunologic, microbial, and biochemical pathways that lead to the development of food allergy [ Time Frame: 06/15/2025 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
National Institutes of Health Clinical Center· Bethesda, MD

Related Studies