Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. (HIMEOS)

January 2, 2015 updated by: Monther Bajbouj, Technical University of Munich

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar, II. Medizinische Klinik
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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;
Two months
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
Two months
Symptoms before/after therapy
Time Frame: Two months
Evaluation of symptoms via questionnaire before/after therapy
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Simon Nennstiel, Dr. med., Klinikum rechts der Isar, II. Med. Klinik
  • Principal Investigator: Christoph Schlag, Dr. med., Klinikum rechts der Isar, II. Med. Klinik
  • Principal Investigator: Monther Bajbouj, PD Dr. med., Klinikum rechts der Isar, II. Med. Klinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 2, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIMEOS-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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