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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07708467

Acronym

DiNAM-EoE-C

Enrollment

Registered

2026-07-16

Start date

2026-05-01

Completion date

2027-08-01

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Esophageal, Eosinophilic Esophagitis (EoE)

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 informed consent.

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 immunosuppressive or biological drugs, or medications affecting esophageal motility (opioids, nitrates, calcium channel blockers); 5. Presence of R3 and/or S1 (according to EREFS).

Design outcomes

Primary

Measure	Time frame	Description
Change in esophageal distensibility plateau, measured by functional lumen imaging probe (FLIP)	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)	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

Secondary

Measure	Time frame	Description
Clinical response to dilation	8-12 week post 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

Countries

Italy

Outcome results