Food Allergy ProvedNCT07039266
Food Allergy Registry and Awareness Campaign in Puerto Rico
An observational study of Food Allergy Proved, run by University of Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Allergy Proved
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Dec 2026
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Food Allergy age 0 to 100 years
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Food Allergy Proved
- Keywords
- Food Allergy, Allergy
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Food Allergy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Questionnaire
Demographics Food Allergy Diagnosis Food Allergy Reactions Most Recent Food Allergy Reaction Specific Food Allergy Comorbidities Management Quality of Life Educational Component
Measured: 25 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy ProvedStudies 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
- Other
- Enrolment
- 151 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Sylvette Nazario, MD, Principal investigator, Universidad de Puerto Rico - Recinto de Ciencias Médicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039266
- Sponsor's protocol ID
- 2502353537A001
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Allergy Registry and Awareness Campaign in Puerto Rico
- ClinicalTrials.gov ID
- NCT07039266
- Acronym / sponsor ID
- 2502353537A001
- Conditions
- Food Allergy Proved
- Keywords
- Food Allergy, Allergy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food Allergy | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Food Allergy age 0 to 100 years
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
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
Participant Questionnaire
Time frame: 25 min
Demographics Food Allergy Diagnosis Food Allergy Reactions Most Recent Food Allergy Reaction Specific Food Allergy Comorbidities Management Quality of Life Educational Component
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 26 Jun 2025.
- Individual participant dataSharing planned: No
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.
Sylvette Nazario, MD principal investigator
Universidad de Puerto Rico - Recinto de Ciencias Médicas
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy Proved, run by University of Puerto Rico.
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 0 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: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Sylvette Nazario, MD (787-448-8420, sylvette.nazario@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Questionnaire (time frame: 25 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.