Clinical Trial: Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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
Sponsor: Technische Universität München

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Technische Universität München

Dates:
Date Received: December 2, 2013
Date Started: October 2013
Date Completion:
Last Updated: January 2, 2015
Last Verified: January 2015