The DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in Eosinophilic Esophagitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Eosinophilic Esophagitis (EoE), Dysphagia, Esophageal. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in a Eosinophilic Esophagitis Cohort With Residual Symptoms Despite Histological Remission
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.
Primary outcome measures
- Change in esophageal distensibility plateau, measured by functional lumen imaging probe (FLIP) [Time frame: 8-12 weeks]
- Change in esophageal body compliance measured by functional lumen imaging probe (FLIP) [Time frame: 8-12 weeks]
Secondary outcome measures (1)
- Clinical response to dilation [Time frame: 8-12 week post dilation]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years;
- Confirmed diagnosis of eosinophilic esophagitis in histological remission (<15 eosinophils/HPF);
- Persistent symptoms (e.g., dysphagia, food impaction, chest pain) despite medical or dietary therapy;
- Stable EoE therapy throughout the study duration (proton pump inhibitors, budesonide, dupilumab, dietary therapies);
- Signed informed consent.
Exclusion criteria
- Previous diagnosis of severe erosive esophagitis (Los Angeles grade C or higher);
- Previous diagnosis of esophagogastric junction outflow disorders (e.g., achalasia);
- Systemic diseases involving the esophagus (e.g., scleroderma);
- Use or initiation during the study of immunosuppressive or biological drugs, or medications affecting esophageal motility (opioids, nitrates, calcium channel blockers);
- Presence of R3 and/or S1 (according to EREFS).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Ospedale Maggiore Policlinico di Milano — Milan
Identifiers
NCT: NCT07708467 · 7054_08.04.2026_P_bis