NCT02504853

Natural History and Genetics of Food Allergy and Related Conditions

Recruiting now Last updated 1 April 2026

What this trial tests

trial in Food Allergy in 1,800 participants. Currently enrolling.

Timeline

29 July 2015

Primary endpoint
15 June 2026

15 June 2026

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,800
Start date	29 July 2015
Primary completion	15 June 2026
Estimated completion	15 June 2026
Sites	1 location across United States

Conditions studied

• Food Allergy — all drugs for Food Allergy →
• Loeys-Dietz Syndrome — all drugs for Loeys-Dietz Syndrome →
• Atopic Dermatitis — all drugs for Atopic Dermatitis →
• Eosinophilic Esophagitis — all drugs for Eosinophilic Esophagitis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 1 Day to 99, any sex, with Food Allergy or Loeys-Dietz Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A unified metric of human immune health.
   Sparks R, Rachmaninoff N, Lau WW, Hirsch DC, et al · · 2024 · cited 37× · PMID 38961223 · DOI 10.1038/s41591-024-03092-6
2. Severe food allergy reactions are associated with α-tryptase.
   Lang A, Kubala S, Grieco MC, Mateja A, et al · · 2023 · cited 27× · PMID 37558059 · DOI 10.1016/j.jaci.2023.07.014
3. Severity of oro-dental anomalies in Loeys-Dietz syndrome segregates by gene mutation.
   Jani P, Nguyen QC, Almpani K, Keyvanfar C, et al · · 2020 · cited 16× · PMID 32152251 · DOI 10.1136/jmedgenet-2019-106678
4. Loeys-Dietz and Shprintzen-Goldberg syndromes: analysis of TGF-β-opathies with craniofacial manifestations using an innovative multimodality method.
   Almpani K, Liberton DK, Jani P, Keyvanfar C, et al · · 2022 · cited 13× · PMID 34916229 · DOI 10.1136/jmedgenet-2021-107695
5. Distinct CRTH2+CD161+ (peTh2) memory CD4+ T-cell cytokine profiles in food allergy and eosinophilic gastrointestinal disorders.
   Makiya MA, Brown T, Holland N, Wetzler L, et al · · 2023 · cited 6× · PMID 37487654 · DOI 10.1111/cea.14376
6. Key factors that influence quality of life in patients with IgE-mediated food allergy vary by age.
   Kubala SA, Young FD, Callier V, Rasooly MM, et al · · 2024 · cited 5× · PMID 39096008 · DOI 10.1111/all.16253
7. Toward precision medicine in vascular connective tissue disorders.
   Ziegler SG, MacCarrick G, Dietz HC. · · 2021 · cited 2× · PMID 34428348 · DOI 10.1002/ajmg.a.62461
8. Audiologic and Otologic Clinical Manifestations of Loeys-Dietz Syndrome: A Heritable Connective Tissue Disorder.
   Jeon JW, Christensen J, Chisholm J, Zalewski C, et al · · 2022 · cited 2× · PMID 33971761 · DOI 10.1177/01945998211008899