Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.

Not Applicable

• Conditions: Eosinophilic Esophagitis
• Interventions: Device: High resolution manometry (HRM)

• Registration Number: NCT02331849
• Lead Sponsor: Technical University of Munich

Brief Summary

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

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-02
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-02
• Last Update Submitted: 2015-01-02
• Study First Posted: 2015-01-06
• Last Update Posted: 2015-01-06
• Primary Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eosinophilic esophagitis	High resolution manometry (HRM)	Patients with eosinophilic esophagitis after exclusion of GERD

Primary Outcome Measures

Name	Time	Method
Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)	Two months	Average maximum intra-bolus-pressure (IBP) \[mmHg\] before and after therapy

Secondary Outcome Measures

Name	Time	Method
Improvement of esophageal motility (e.g. specified in the chicago classification) represented in high resolution manometry (HRM)	Two months	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;
Endoscopic evaluation of inflammation before/after therapy	Two months	Endoscopic assessment of esophageal signs of eosinophilic esophagitis (white exsudates, furrows, edema, rings, crepe paper, stricture
Symptoms before/after therapy	Two months	Evaluation of symptoms via questionnaire before/after therapy

Trial Locations

Locations (1)

Klinikum rechts der Isar, II. Medizinische Klinik; 🇩🇪 München, Germany