Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population

Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population: a Multicentric Prospective Study in Italy

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.

Study Overview

• Status: Recruiting
• Conditions: Eosinophilic Esophagitis (EoE)

Detailed Description

Two phases multicentre prospective observational study. In the first phase of the study, the Italian version of DSQ will be validated. In the second phase of the study, the clinical outcome of EoE patients will be investigated. Patients enrolled in the first phase will also enter in the second phase. For exploratory aim, serum and oesophageal tissue samples will be collected only in patient enrolled in S. C. General MedicineI.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Contact: Antonio Di Sabatino, Medicine; Phone Number: 0382 502973; Email: a.disabatino@smatteo.pv.it
      • Contact: Carlo Rossi, Medicine; Phone Number: 00390382502842; Email: ca.rossi@smatteo.pv.it
    • Pavia, Pavia, Italy, 27100
      • Recruiting
      • S. C. General Medicine I, Fondazione IRCCS Policlinico San MAtteo
      • Contact: Carlo Rossi, Medicine; Phone Number: 00390382502842; Email: ca.rossi@smatteo.pv.it
      • Contact: Antonio Di Sabatino, Medicine; Phone Number: 00390382502973; Email: a.disabatino@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

Inclusion Criteria:

• patients with an established diagnosis of Eosinophilic esophagitis;
• aged ≥5 years;
• who gave written informed consent.

Exclusion Criteria:

• under 5 years old;
• Patients who are illiterate;
• Patients who are unwilling to participate

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adult cohort
Paediatric cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 months afterwards the enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
To estimate the maintenance of remission in the follow-up period both in EoE adult and paediatric patients.	every year for 5 years total

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Eosinophilic Esophagitis (EoE); NATURAL HISTORY; Dysphagia Symptom Questionnaire
• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis
• Other Study ID Numbers: P_473

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No