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

NCT07708467 | Enrolling By Invitation

• 1 other identifier: 7054_08.04.2026_P_bis
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eosinophilic Esophagitis (EoE); Dysphagia, Esophageal

Keywords

EOE; FLIP; Functional Lumen Imaging Probe; dilation; eosinophilic esophagitis

Outcome Measures

Primary Outcomes (2)

• 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

  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

  8-12 weeks

Secondary Outcomes (1)

• Clinical response to dilation

  8-12 week post dilation

Study Arms (1)

EoE Patients in Histologic Remission with persistent symptoms

EoE Patients in Histologic Remission with persistent symptoms without strictures underwent dilation and FLIP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients with confirmed eosinophilic esophagitis who are in regular clinical follow-up at one of the referral hospitals participating in the study, have achieved histologic remission, defined as fewer than 15 eosinophils/HPF on esophageal biopsies, but continue to experience persistent symptoms such as dysphagia, chest pain, or food impaction despite stable EoE therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• Azienda Ospedaliera di Padova: collaborator
• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: collaborator

Study Sites (1)

Ospedale Maggiore Policlinico di Milano

Milan, MI, 20122, Italy

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Deglutition Disorders; Dilatation, Pathologic

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; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor (MD, PhD)

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)