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A Registry for the Food Allergy Community (FPR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04653324
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Food Allergy Research & Education

Study Description
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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.

Condition or disease
Food Hypersensitivity Anaphylaxis Eosinophilic Esophagitis Food Sensitivity Food Intolerance Food Allergy in Infants

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 23000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The FARE Patient Registry: A Registry for the Food Allergy Community
Actual Study Start Date : August 24, 2017
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development. [ Time Frame: 2023 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • Individuals with diagnosed food allergy

Exclusion Criteria:

  • Individuals without food allergy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653324


Contacts
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Contact: Patient Registry Coordinator 1-800-929-4040 farepatientregistry@foodallergy.org

Locations
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United States, Virginia
Food Allergy Research & Education Recruiting
McLean, Virginia, United States, 22102
Contact: FARE Patient Registry Coordinator         
Sponsors and Collaborators
Food Allergy Research & Education
Investigators
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Principal Investigator: Bruce Roberts, PhD Food Allergy Research & Education
More Information
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Publications:

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Responsible Party: Food Allergy Research & Education
ClinicalTrials.gov Identifier: NCT04653324    
Other Study ID Numbers: Pro00022715
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Food Allergy Research & Education:
food allergy
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Hypersensitivity
Food Hypersensitivity
Anaphylaxis
Food Intolerance
Immune System Diseases
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Hypersensitivity, Immediate
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Signs and Symptoms, Digestive