Food HypersensitivityFPRNCT04653324
A Registry for the Food Allergy Community
An observational study of Food Hypersensitivity and Anaphylaxis, run by Food Allergy Research & Education at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Hypersensitivity, Anaphylaxis, Eosinophilic Esophagitis
- How many people
- 23,000 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to Aug 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older 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.
Who may be able to join
- Individuals with diagnosed food allergy
Who cannot join
- Individuals without food allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Food Allergy Research & Education
McLean, Virginia, 22102
FARE Patient Registry Coordinator
About this study
Official title: 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.
- Conditions
- Food Hypersensitivity, Anaphylaxis, Eosinophilic Esophagitis, Food Sensitivity, Food Intolerance, Food Allergy in Infants
- Keywords
- food allergy
- Medical subject headings
- Food Hypersensitivity, Anaphylaxis, Eosinophilic Esophagitis, Food Intolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development.
Measured: 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start24 Aug 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Food Allergy Research & Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Bufford, MS, Principal investigator, Food Allergy Research & Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653324
- Sponsor's protocol ID
- Pro00022715
- Acronym
- FPR
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32841746Oriel 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.
PubMed 33338685Gupta 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.
PubMed 34033980Casale 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.
PubMed 38559493Warren 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.
PubMed 38523669
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FARE Patient Registry: A Registry for the Food Allergy Community
- ClinicalTrials.gov ID
- NCT04653324
- Acronym / sponsor ID
- FPR / Pro00022715
- Conditions
- Food Hypersensitivity, Anaphylaxis, Eosinophilic Esophagitis, Food Sensitivity, Food Intolerance, Food Allergy in Infants
- Keywords
- food allergy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 23,000 participants (estimated)
- Lead sponsor
- Food Allergy Research & EducationUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Individuals with diagnosed food allergy
Key exclusion criteria (1 listed)
- Individuals without food allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development.
Time frame: 2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 32841746Fierstein 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.
- Background: PubMed 33338685Oriel 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.
- Background: PubMed 34033980Gupta 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.
- Derived from this study: PubMed 38559493Casale 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.
- Derived from this study: PubMed 38523669Warren 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Bufford, MS principal investigator
Food Allergy Research & Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Hypersensitivity and Anaphylaxis, run by Food Allergy Research & Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patient Registry Coordinator (1-800-929-4040, farepatientregistry@foodallergy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development. (time frame: 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04653324, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.