Eosinophilic EsophagitisNCT05755477
Survey About the Relationship Beetween Allergic Rhinitis and Seasonal EOE Exacerbations
An observational study of Eosinophilic Esophagitis and Respiratory Allergy, run by Nucera Eleonora at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eosinophilic Esophagitis, Respiratory Allergy
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: All the subjects (both sex) between 18 and 75 years old with EOE diagnosis
Who may be able to join
- All the subjects with EOE diagnosis
Who cannot join
- All the patients without EOE diagnosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Arianna Aruanno, MD, PhD, 393282190241, arianna.aruanno@policlinicogemelli.it
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Eosinophilic Esophagitis, Respiratory Allergy
- Medical subject headings
- Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start3 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nucera Eleonora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nucera Eleonora, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755477
- Sponsor's protocol ID
- 3638
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey About the Relationship Beetween Allergic Rhinitis and Seasonal EOE Exacerbations: the Role of Respiratory Allergy in the EOE Etiopathogenesis
- ClinicalTrials.gov ID
- NCT05755477
- Acronym / sponsor ID
- 3638
- Conditions
- Eosinophilic Esophagitis, Respiratory Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nucera EleonoraUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Mar 2023 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All the subjects (both sex) between 18 and 75 years old with EOE diagnosis
Key inclusion criteria (1 listed)
- All the subjects with EOE diagnosis
Key exclusion criteria (1 listed)
- All the patients without EOE diagnosis
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
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.
2 secondary outcomes
Correlation between the anamnestic onset of the disease and the individual patient's sensitization to aeroallergens.
Time frame: 12 months
Prevalence of respiratory allergy (rhinitis and allergic asthma) in patients with EoE.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis and Respiratory Allergy, run by Nucera Eleonora at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleonora NUCERA, PROF. (390630154965, eleonora.nucera@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the recrudescence of dysphagia symptoms and Seasons (time frame: 12 months). 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 6 Mar 2023.