Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population

NCT07614633 | Recruiting

• 1 other identifier: P_473
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Eosinophilic Esophagitis (EoE)

Keywords

NATURAL HISTORY; Eosinophilic Esophagitis (EoE); Dysphagia Symptom Questionnaire

Outcome Measures

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.

  1 months afterwards the enrollment

Secondary Outcomes (1)

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

  every year for 5 years total

Study Arms (2)

Adult cohort

Adult cohort

Paediatric cohort

Paediatric cohort

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (2)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

S. C. General Medicine I, Fondazione IRCCS Policlinico San MAtteo

Pavia, Pavia, 27100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oesophageal biopsies will be collected during oesophageal endoscopy, as planned for routinary clinical practice. Blood samples (serum) will be collected during blood test, as planned for routinary clinical practice. The evaluation of local (oesophageal tissue) and systemic (as determined in the peripheral blood) will allow the characterization of biomarkers for diagnostic and predictive purposes. More precisely, the evaluation of the alteration of the vascular barrier (through plasmalemmal vesiscle-1, PV-1, assessment) may allow the diagnosis of EoE even in the absence of strict histological criteria and may serve as correlate of disease clearance after therapy. Moreover, the analysis may allow the identification of patients characterized by the rapid development of fibrosis who may need a more aggressive management.

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of General Medicine I Unit

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 29, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 29, 2026

Record last verified: 2025-08

Locations

IT (2)