NCT05755477

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

February 21, 2023

Last Update Submit

March 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

    12 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All the subjects with EOE diagnosis

You may not qualify if:

  • All the patients without EOE diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 6, 2023

Study Start

January 3, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations