Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

Eosinophilic esophagitis (EoE) is a Th2-mediated disease induced by ingestion of ambiental and alimentary allergens. Incidence of EoE is increasing in recent years. Young male subjects are more often affected by EoE. Esophageal eosinophilic infiltrate causes different symptoms of esophageal dysfunction (i.e. dysphagia, food impaction, chest pain, heartburn). In pediatric population symptoms are nonspecific (failure to thrive, vomiting) and more common to be misdiagnosed.

Symptoms are commonly sporadic and underestimated by the patients. Therefore, specialistic evaluations are often delayed during the following months and years. Moreover, esophageal symptoms are often not investigated or associated with other diseases especially in pediatric population (i.e. gastroesophageal reflux disease). For this reason, diagnosis of EoE is often delayed. It is known from literature that diagnostic delay in EoE causes prolonged inflammation of the esophagus that may lead to esophageal fibrosis and stenosis with worsening of symptoms. Proton pump inhibitors (PPIs) and topical steroids are the first line medicines to induce EoE remission. Prolonged clinical remission is described in 60% of adult patients with PPIs. Recently orodispersible budesonide showed clinical remission after 1 year nearby in 90% of adult patients. Orodispersible budesonide is effective also in chidren with an efficacy in maintaining remission at lowest effective dosage after 60 weeks in around 78% of patients. Dysphagia Symptom Questionnaire (DSQ) is a validated tool used in order to measure clinical activity (dysphagia) in adult and pediatric patients with EoE. Italian version of the DSQ is not available in literature. Little is known in literature about the natural history of EoE patients, in particular about sustained clinical remission and appearance of complications (i.e. food impaction) during a prolonged follow-up period. Aim of our two-phase prospective study is to evaluate the clinical and endoscopic response at the current available therapies and the appearance of complications during a prolonged follow-up period in a cohort of adult and pediatric population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with an established diagnosis of Eosinophilic esophagitis;

aged ≥5 years;

who gave written informed consent.

Disqualifiers

under 5 years old;

Patients who are illiterate;

Patients who are unwilling to participate

Trial population

Eosinophilic esophagitis patients who will access to the Endoscopy unit or to the Clinic "Medicina Generale 1" and to the others involved Centers will be consecutively enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Adult cohort
Group B: Paediatric cohort

Trial outcomes

Primary outcomes

1

To evaluate the repeatability (test-retest reliability) of the Italian version of DSQ questionnaire at enrollment and at 1 months afterwards.

The Intraclass correlation coefficient (ICC) will be calculated to evaluate the test-retest reliability of the Italian version of DSQ questionnaire.

Time frame
1 months afterwards the enrollment

Secondary outcomes

1

Maintenance of remission in the follow-up period in both in EoE adult and paediatric patients.

To calculate the cumulative proportion of maintenance of remission in the follow-up period will be estimated using Kaplan-Meier failure estimator both in EoE adult and paediatric patients.

Time frame
every year for 5 years total

Other outcomes

Sponsors and contacts

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