- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04653324
A Registry for the Food Allergy Community (FPR)
February 21, 2024 updated by: Food Allergy Research & Education
The FARE Patient Registry: A Registry for the Food Allergy Community
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
23000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patient Registry Coordinator
- Phone Number: 1-800-929-4040
- Email: farepatientregistry@foodallergy.org
Study Locations
-
-
Virginia
-
McLean, Virginia, United States, 22102
- Recruiting
- Food Allergy Research & Education
-
Contact:
- FARE Patient Registry Coordinator
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-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.
Description
Inclusion Criteria:
- Individuals with diagnosed food allergy
Exclusion Criteria:
- Individuals without food allergy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development.
Time Frame: 2023
|
2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer Bufford, MS, Food Allergy Research & Education
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2017
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
November 27, 2020
First Submitted That Met QC Criteria
November 27, 2020
First Posted (Actual)
December 4, 2020
Study Record Updates
Last Update Posted (Actual)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Gastroenteritis
- Esophageal Diseases
- Leukocyte Disorders
- Eosinophilia
- Hypersensitivity
- Eosinophilic Esophagitis
- Esophagitis
- Food Hypersensitivity
- Food Intolerance
- Anaphylaxis
Other Study ID Numbers
- Pro00022715
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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