A Registry for the Food Allergy Community | NCT04653324

Studies
A Registry for the Food Allergy Community

NCT04653324

Sponsor

Food Allergy Research & Education

Status

Recruiting

Last Update Posted

Mar 12, 2025Actual

Enrollment

23,000Estimated

Phase

Not provided

Conditions

Food Hypersensitivity
Anaphylaxis
Eosinophilic Esophagitis
Food Sensitivity
Food Intolerance
Food Allergy in Infants

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2017Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Nov 27, 2020

First Submission Date that Met QC Criteria

Nov 27, 2020

First Posted Date

Dec 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development.		2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals with diagnosed food allergy

Exclusion Criteria:

Individuals without food allergy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patient Registry Coordinator	Contact	1-800-929-4040		farepatientregistry@foodallergy.org

Overall Officials

Name	Affiliation	Role
Jennifer Bufford, MS	Food Allergy Research & Education	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Food Allergy Research & Education	Recruiting	McLean	Virginia	22102	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32841746	Background	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.
33338685	Background	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.

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D004941	Esophagitis

ID	Term
D005512	Food Hypersensitivity
D000707	Anaphylaxis
D057765	Eosinophilic Esophagitis
D000073923	Food Intolerance