Survey About the Relationship Beetween Allergic Rhinitis and Seasonal EOE Exacerbations

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755477
• Other study ID #: 3638
• Status: Recruiting
• Start date: January 3, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Eleonora NUCERA, PROF.
• Phone: 390630154965
• Email: eleonora.nucera[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All the subjects with EOE diagnosis

Exclusion Criteria:

• All the patients without EOE diagnosis

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis
• Hypersensitivity
• Respiratory Allergy
• Rhinitis
• Rhinitis, Allergic

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Nucera Eleonora

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the recrudescence of dysphagia symptoms and Seasons	Evaluate the possible correlation between the recrudescence of dysphagia symptoms and a specific month of the year and/or specific season.	12 months
Secondary	Correlation between the anamnestic onset of the disease and the individual patient's sensitization to aeroallergens.	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
Secondary	Prevalence of respiratory allergy (rhinitis and allergic asthma) in patients with EoE.	Evaluate the prevalence of respiratory allergy (rhinitis and allergic asthma) in patients with EoE.	12 months