NCT07039266

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

June 18, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

Food AllergyAllergy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Food Allergy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Food Allergy age 0 to 100 years

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Food HypersensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Sylvette Nazario, MD

    Universidad de Puerto Rico - Recinto de Ciencias Médicas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvette Nazario, MD

CONTACT

Bonnie Telon Sosa, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share