Food Allergy Registry and Awareness Campaign in Puerto Rico

Food Allergies affect 8% of children and 11% of adults, and there are increasing trends worldwide. Suffering food allergies reduces the quality of life and increases ED visits, hospitalizations, and mortality. Minorities in the United States suffer an increased food allergy burden, with higher prevalence, morbidity, and decreased use of preventive measures. Limited information is available in Puerto Rico. Moreover, advances in food allergy diagnostics, prevention, and treatment offer new hope for patients. We aim to develop a de-identified physician-diagnosed food allergy registry in Puerto Rico to characterize the food allergy population demographics, comorbidities, healthcare use, treatment, and quality of life. Our second aim is to educate patients with web-based posts to improve knowledge and awareness of food allergies.

Study Overview

• Status: Not yet recruiting
• Conditions: Food Allergy Proved

• Study Type: Observational
• Enrollment (Estimated): 151

Contacts and Locations

• Study Contact: Name: Sylvette Nazario, MD; Phone Number: 787-448-8420; Email: sylvette.nazario@upr.edu
• Study Contact Backup: Name: Bonnie Telon Sosa, MPH; Phone Number: 787-619-5712; Email: bonnie.telon@upr.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Food Allergy age 0 to 100 years

Description

Inclusion Criteria:

• We will recruit Puerto Rican residents aged 0 -100 years diagnosed with food allergies by board-certified allergists. A food allergy diagnosis requires a positive prick skin test or specific IgE and a history of anaphylaxis or the development of cutaneous, respiratory, cardiovascular, or vomiting within 2 hours of ingestion or a positive food challenge.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Food Allergy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Questionnaire	Demographics Food Allergy Diagnosis Food Allergy Reactions Most Recent Food Allergy Reaction Specific Food Allergy Comorbidities Management Quality of Life Educational Component	25 min

Collaborators and Investigators

• Sponsor: University of Puerto Rico
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Sylvette Nazario, MD, Universidad de Puerto Rico - Recinto de Ciencias Médicas

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Allergy; Food Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 2502353537A001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No