Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.

Eosinophilic Esophagitis Clinical Trial

— HIMEOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331849
• Other study ID #: HIMEOS-2013
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2013
• Last updated: January 2, 2015
• Start date: October 2013

Study information

• Verified date: January 2015
• Source: Technische Universität München
• Contact: Simon Nennstiel
• Phone: +49 89 4140 5055
• Email: simon.nennstiel[@]lrz.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Device:
• High resolution manometry (HRM)
High resolution manometry of the esophagus

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar, II. Medizinische Klinik	München

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)	Average maximum intra-bolus-pressure (IBP) [mmHg] before and after therapy	Two months	No
Secondary	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	No
Secondary	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	No
Secondary	Symptoms before/after therapy	Evaluation of symptoms via questionnaire before/after therapy	Two months	No