Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.

Study Overview
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Brief Summary
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Esophageal Motility in eosinophilic esophagitis will be evaluated by High Resolution Manometry before and after medical treatment - motility is suspected to change/improve after therapy.

Detailed Description
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After identification of eosinophilic inflammation of the esophagus -> differentiation between GERD and eosinophilic esophagitis (via pH/MII-measurements or PPI-trial) -> High-resolution manometry (HRM) for evaluation of esophageal motility in patients with eosinophilic esophagitis (exclusion of GERD-patients)-> initiation of budesonide-therapy -> after eight weeks of therapy reevaluation of esophageal motility by HRM

Official Title
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Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry - Effect on Esophageal Motility of Standard Therapy.

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Device: High resolution manometry (HRM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • patients with eosinophilic inflammation of the esophagus Exclusion Criteria: refusal to participate in study pregnancy eosinophilic gastroenteritis Achalasia contraindication for gastroscopy / HRM / 24-h-pH/Impedance-monitoring contraindication for therapy with budesonide eosinophilic inflammation due to GERD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eosinophilic esophagitis<br>Patients with eosinophilic esophagitis after exclusion of GERD | Device: High resolution manometry (HRM)<br>* High resolution manometry of the esophagus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM) | Average maximum intra-bolus-pressure (IBP) [mmHg] before and after therapy | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of esophageal motility (e.g. specified in the chicago classification) represented in high resolution manometry (HRM) | weak peristalsis with small/large breaks, frequently failes peristalsis, absent peristalsis, hypertensive peristalsis, rapid contractions with normal latency, functional EGJ-obstruction, panesophageal pressurizations, compartimentalized pressurizations; | Two months | 
| Endoscopic evaluation of inflammation before/after therapy | Endoscopic assessment of esophageal signs of eosinophilic esophagitis (white exsudates, furrows, edema, rings, crepe paper, stricture | Two months | 
| Symptoms before/after therapy | Evaluation of symptoms via questionnaire before/after therapy | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophilic esophagitis (EoE), GERD, esophageal motility