The DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in Eosinophilic Esophagitis

N/AEnrolling By InvitationNCT07708467

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico25 enrolled

Overview

Eosinophilic esophagitis is a chronic immune-mediated disease that may progress to fibrostenotic remodeling, leading to symptoms such as dysphagia, chest pain, and food impaction. Although current therapies aim to achieve inflammatory control and prevent fibrosis, some patients remain symptomatic despite endoscopic and histologic remission. In this subgroup, symptoms may reflect reduced esophageal distensibility, motility abnormalities, or altered symptom perception related to hypervigilance. This study aims to evaluate symptomatic EoE patients in histologic remission by assessing esophageal distensibility with FLIP before and after endoscopic dilation, investigating motility abnormalities with HRM, and exploring the role of hypervigilance in clinical outcomes.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eosinophilic Esophagitis (EoE)Dysphagia, Esophageal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years; 2. Confirmed diagnosis of eosinophilic esophagitis in histological remission (\<15 eosinophils/HPF); 3. Persistent symptoms (e.g., dysphagia, food impaction, chest pain) despite medical or dietary therapy; 4. Stable EoE therapy throughout the study duration (proton pump inhibitors, budesonide, dupilumab, dietary therapies); 5. Signed informed consent. Exclusion Criteria: 1. Previous diagnosis of severe erosive esophagitis (Los Angeles grade C or higher); 2. Previous diagnosis of esophagogastric junction outflow disorders (e.g., achalasia); 3. Systemic diseases involving the esophagus (e.g., scleroderma); 4. Use or initiation during the study of immunosuppressive or biological drugs, or medications affecting esophageal motility (opioids, nitrates, calcium channel blockers); 5. Presence of R3 and/or S1 (according to EREFS).

Outcomes

Primary Outcomes

Change in esophageal distensibility plateau, measured by functional lumen imaging probe (FLIP)

Change in esophageal distensibility plateau (mm) measured by functional lumen imaging probe (FLIP) from baseline to 8-12 weeks post dilation

Time frame: 8-12 weeks

Change in esophageal body compliance measured by functional lumen imaging probe (FLIP)

Change in esophageal body compliance (mm²/mmHg), measured by functional lumen imaging probe (FLIP) from baseline to 8-12 weeks post dilation

Time frame: 8-12 weeks

Secondary Outcomes

Clinical response to dilation

Clinical response was assessed using the Eosinophilic Esophagitis Activity Index (EEsAI) questionnaire (score range: 0-100, with higher scores indicating greater symptom severity). Clinical response was defined as either a significant reduction in the EEsAI score from baseline or clinical remission, defined as an EEsAI score \<20

Time frame: 8-12 week post dilation