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Clinical Trials/NCT02331849
NCT02331849
Unknown
Not Applicable

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

Technical University of Munich1 site in 1 country20 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eosinophilic Esophagitis
Sponsor
Technical University of Munich
Enrollment
20
Locations
1
Primary Endpoint
Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)
Last Updated
11 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
February 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Principal Investigator
Principal Investigator

Monther Bajbouj

PD Dr. med.

Technical University of Munich

Eligibility Criteria

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

Outcomes

Primary Outcomes

Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)

Time Frame: Two months

Average maximum intra-bolus-pressure (IBP) \[mmHg\] before and after therapy

Secondary Outcomes

  • Improvement of esophageal motility (e.g. specified in the chicago classification) represented in high resolution manometry (HRM)(Two months)
  • Endoscopic evaluation of inflammation before/after therapy(Two months)
  • Symptoms before/after therapy(Two months)

Study Sites (1)

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