NCT04653324

Brief Summary

The FARE Patient Registry will serve as a prospective, observational food allergy reporting system that stores detailed health and other basic information about patients' real-world experiences with food allergies, to encourage open sharing of de-identified data and participation in clinical trials. The FARE Patient Registry intends to make and support scientific discoveries by enabling the food allergy community to participate directly in research.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23,000

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Aug 2017Aug 2027

Study Start

First participant enrolled

August 24, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

9.9 years

First QC Date

November 27, 2020

Last Update Submit

March 10, 2025

Conditions

Food HypersensitivityAnaphylaxisEosinophilic EsophagitisFood SensitivityFood IntoleranceFood Allergy in Infants

Keywords

food allergy

Outcome Measures

Primary Outcomes (1)

  • Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development.

    2023

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population includes males and females of all ages with one or more food allergy or those who are at risk of food-induced anaphylaxis.

You may qualify if:

  • Individuals with diagnosed food allergy

You may not qualify if:

  • Individuals without food allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Allergy Research & Education

McLean, Virginia, 22102, United States

RECRUITING

Related Publications (5)

  • Fierstein JL, Brown D, Gupta R, Bilaver L. Understanding Food-Related Allergic Reactions Through a US National Patient Registry. J Allergy Clin Immunol Pract. 2021 Jan;9(1):206-215.e1. doi: 10.1016/j.jaip.2020.08.011. Epub 2020 Aug 22.

    PMID: 32841746BACKGROUND

  • Oriel RC, Waqar O, Sharma HP, Casale TB, Wang J. Characteristics of Food Allergic Reactions in United States Restaurants. J Allergy Clin Immunol Pract. 2021 Apr;9(4):1675-1682. doi: 10.1016/j.jaip.2020.12.018. Epub 2020 Dec 15.

    PMID: 33338685BACKGROUND

  • Gupta RS, Sehgal S, Brown DA, Das R, Fierstein JL, Casale TB, Nowak-Wegrzyn AH, Bilaver LA. Characterizing Biphasic Food-Related Allergic Reactions Through a US Food Allergy Patient Registry. J Allergy Clin Immunol Pract. 2021 Oct;9(10):3717-3727. doi: 10.1016/j.jaip.2021.05.009. Epub 2021 May 24.

    PMID: 34033980BACKGROUND

  • Casale TB, Warren C, Gupta S, Schuldt R, Wang R, Iqbal A, Seetasith A, Gupta R. The mental health burden of food allergies: Insights from patients and their caregivers from the Food Allergy Research & Education (FARE) Patient Registry. World Allergy Organ J. 2024 Mar 23;17(4):100891. doi: 10.1016/j.waojou.2024.100891. eCollection 2024 Apr.

    PMID: 38559493DERIVED

  • Warren C, Gupta R, Seetasith A, Schuldt R, Wang R, Iqbal A, Gupta S, Casale TB. The clinical burden of food allergies: Insights from the Food Allergy Research & Education (FARE) Patient Registry. World Allergy Organ J. 2024 Mar 15;17(3):100889. doi: 10.1016/j.waojou.2024.100889. eCollection 2024 Mar.

    PMID: 38523669DERIVED

MeSH Terms

Conditions

Food HypersensitivityAnaphylaxisEosinophilic EsophagitisFood Intolerance

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesEsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Bufford, MS

    Food Allergy Research & Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patient Registry Coordinator

CONTACT

1-800-929-4040farepatientregistry@foodallergy.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 4, 2020

Study Start

August 24, 2017

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

US(1)