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Enrolling by Invitation

NCT Number: NCT07708467

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

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.

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Key information

Conditions

Eosinophilic Esophagitis (EoE) Deglutition Disorders Digestive System Diseases Dilatation, Pathologic Dysphagia, Esophageal Eosinophilia Eosinophilic Esophagitis Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Maggiore Policlinico di Milano

Milan, MI, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Change in esophageal distensibility plateau

    Time frame: 8-12 weeks

    Change in esophageal distensibility plateau (mm) from baseline to 8-12 weeks post dilation

  2. Change in esophageal body compliance

    Time frame: 8-12 weeks

    Change in esophageal body compliance (mm²/mmHg) from baseline to 8-12 weeks post dilation

Secondary outcomes

  1. Clinical response to dilation

    Time frame: 8-12 week post dilation

    EESAI<20 points

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • Azienda Ospedaliera di Padova
  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Registry information

Official study title

The DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in a Eosinophilic Esophagitis Cohort With Residual Symptoms Despite Histological Remission

Acronym: DiNAM-EoE-C

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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