Ireland
--:--IST
Enrolling by invitation Observational

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

NCT07708467 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-05-01
Last updated
2026-07-29

Condition(s) studied

Eosinophilic Esophagitis (EoE)Dysphagia, Esophageal

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Ospedale Maggiore Policlinico di Milano Milan MI
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07708467 on ClinicalTrials.gov ↗ ← All trials in Italy