Natural History and Genetics of Food Allergy and Related Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-99
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
GENERAL
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
Disqualifiers
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.
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)
Trial population
primary clinical
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,800 Participants
are grouped into 4 trial groupsGroup A: Affected Genetic
Group B: Affected Non-Syndromic Food
Group C: Allergic GI Disease
Group D: Unaffected Relative / Healthy Volunteer
Trial outcomes
Primary outcomes
1
Investigate the key genetic, cellular, immunologic, microbial, and biochemical pathways that lead to the development of food allergy
Investigate the key genetic, cellular, immunologic, microbial, and biochemical pathways that lead to the development of food allergy
Time frame
06/15/20252
Identify biomarkers that predict the clinical course and natural history of patients with food allergy
Identify biomarkers that predict the clinical course and natural history of patients with food allergy
Time frame
06/15/2025Secondary outcomes
1
The prevalence of eosinophilic GI disease in patients who might be considered to be at high risk for these conditions, including those patients with atopic dermatitis and/or multiple food sensitivities/allergies
Time frame
06/15/20252
In vitro testing of novel therapies for food allergy using cells and other biological specimens obtained from patients with food allergy
Time frame
06/15/20253
Identification of nutritional deficiencies and their effect on the growth and overall health of patients with food allergy and related conditions
Time frame
06/15/2025Sponsors and contacts
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Source ClinicalTrials.gov