Survey About the Relationship Beetween Allergic Rhinitis and Seasonal EOE Exacerbations

March 2, 2023 updated by: Nucera Eleonora

Survey About the Relationship Beetween Allergic Rhinitis and Seasonal EOE Exacerbations: the Role of Respiratory Allergy in the EOE Etiopathogenesis

Eosinophilic esophagitis (EoE) is a chronic inflammatory esophagus disease that is presented in patients with a history of recurrent dysphagia.

EoE is closely related to other pathologies with an immuno-allergic etiopathogenesis such as atopic dermatitis (AD), IgE-mediated food allergy, allergic rhinitis and bronchial asthma.

While the importance of the correlation between diet and food allergy has been largely demonstrated, less is known about the exact role of sensitization to aerollergens in the progression and recrudescence of symptoms.

In support of this correlation there is evidence of a seasonal trend in the new diagnoses of EoE, of the possibility of the de-novo onset of the pathology following massive exposure to a specific aeroallergen and the demonstration that the degree of esophageal eosinophilia varies according to the climatic zone and the season of the year.

The detailed knowledge of this correlation could clarify some aspects of the etiopathogenesis and natural history of EoE, improve and personalize the clinical-diagnostic management of affected patients and provide new therapeutic targets.

Our aim is evaluating the possible existence of a correlation between the recrudescence of dysphagia symptoms and a specific month of the year and/or specific season.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Eosinophilic esophagitis (EoE) is a chronic inflammatory esophagus disease that is presented in patients with a history of recurrent dysphagia.

EoE is closely related to other pathologies with an immuno-allergic etiopathogenesis such as atopic dermatitis (AD), IgE-mediated food allergy, allergic rhinitis and bronchial asthma.

While the importance of the correlation between diet and food allergy has been largely demonstrated, less is known about the exact role of sensitization to aerollergens in the progression and recrudescence of symptoms.

In support of this correlation there is evidence of a seasonal trend in the new diagnoses of EoE, of the possibility of the de-novo onset of the pathology following massive exposure to a specific aeroallergen and the demonstration that the degree of esophageal eosinophilia varies according to the climatic zone and the season of the year.

The detailed knowledge of this correlation could clarify some aspects of the etiopathogenesis and natural history of EoE, improve and personalize the clinical-diagnostic management of affected patients and provide new therapeutic targets.

It is a cross-sectional observational study and the aim is:

  • evaluating the possible existence of a correlation between the recrudescence of dysphagia symptoms and a specific month of the year and/or specific season
  • evaluating whether there is a statistically significant correlation between the anamnestic onset of the disease and the individual patient's sensitization to aeroallergens and the prevalence of respiratory allergy (rhinitis and allergic asthma) in patients with EoE.

All the patient should answer a questionnaire about the state of health over the year and according to the various pollen seasons

The questionnaire is made up of 18 questions which aim to investigate:

  • anamnestic data (age, weight, height, clinical onset of the pathology);
  • dysphagia symptomatology through modified DSQ (Dysphagia Symptom Questionnaire);
  • rhinitis symptomatology SFAR (Score For Allergic Rhinitis);
  • trend of exacerbations of dysphagia symptoms in the different months of the year.

The aforementioned data aim to investigate the rhinitis and dysphagia symptoms of the patients in the last 12 months.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the subjects (both sex) between 18 and 75 years old with EOE diagnosis

Description

Inclusion Criteria:

  • All the subjects with EOE diagnosis

Exclusion Criteria:

  • All the patients without EOE diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the recrudescence of dysphagia symptoms and Seasons
Time Frame: 12 months
Evaluate the possible correlation between the recrudescence of dysphagia symptoms and a specific month of the year and/or specific season.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the anamnestic onset of the disease and the individual patient's sensitization to aeroallergens.
Time Frame: 12 months
Evaluate whether there is a statistically significant correlation between the anamnestic onset of the disease and the individual patient's sensitization to aeroallergens.
12 months
Prevalence of respiratory allergy (rhinitis and allergic asthma) in patients with EoE.
Time Frame: 12 months
Evaluate the prevalence of respiratory allergy (rhinitis and allergic asthma) in patients with EoE.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nucera Eleonora

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Estimate)

March 6, 2023

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3638

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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