ClinicalTrials.gg
Enrolling by invitationNCT07708467DiNAM-EoE-CUpdated Jul 29, 2026

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

An observational study in Eosinophilic Esophagitis (EoE) and Dysphagia, Esophageal, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Eosinophilic Esophagitis (EoE)
  • Dysphagia, Esophageal

Keywords

  • EOE
  • FLIP
  • Functional Lumen Imaging Probe
  • dilation
  • eosinophilic esophagitis
03

In context

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

This study's planned enrollment of 25 is below the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.

Browse Eosinophilic Esophagitis studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 or biological drugs, or medications affecting esophageal motility (opioids, nitrates, calcium channel blockers);
  5. Presence of R3 and/or S1 (according to EREFS).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Groups and cohorts

  • EoE Patients in Histologic Remission with persistent symptoms

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

07

Study locations

1 site
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07708467
Collaborators
Azienda Ospedaliera di Padova, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Responsible party
Marina Coletta (Attending Doctor (MD, PhD), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico) — Principal investigator
First posted
Jul 16, 2026
Start date
May 1, 2026
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Jul 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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