Eosinophilic Esophagitis (EoE)DiNAM-EoE-CNCT07708467
The DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis (EoE) and Dysphagia, Esophageal, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis (EoE), Dysphagia, Esophageal
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Keywords
- EOE, FLIP, Functional Lumen Imaging Probe, dilation, eosinophilic esophagitis
- Medical subject headings
- Eosinophilic Esophagitis, Deglutition Disorders, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EoE Patients in Histologic Remission with persistent symptoms | EoE Patients in Histologic Remission with persistent symptoms without strictures underwent dilation and FLIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 8-12 week post dilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 May 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Responsible party
- Principal investigator, Marina Coletta, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708467
- Sponsor's protocol ID
- 7054_08.04.2026_P_bis
- Acronym
- DiNAM-EoE-C
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07708467
- Acronym / sponsor ID
- DiNAM-EoE-C / 7054_08.04.2026_P_bis
- Keywords
- EOE, FLIP, Functional Lumen Imaging Probe, dilation, eosinophilic esophagitis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EoE Patients in Histologic Remission with persistent symptoms | – | –EoE Patients in Histologic Remission with persistent symptoms without strictures underwent dilation and FLIP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in esophageal distensibility plateau, measured by functional lumen imaging probe (FLIP)
Time frame: 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)
Time frame: 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
1 secondary outcome
Clinical response to dilation
Time frame: 8-12 week post dilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis (EoE) and Dysphagia, Esophageal, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in esophageal distensibility plateau, measured by functional lumen imaging probe (FLIP) (time frame: 8-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.