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Trial record 4 of 141 for:    "eosinophilic esophagitis"

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

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ClinicalTrials.gov Identifier: NCT02331849
Recruitment Status : Unknown
Verified January 2015 by Monther Bajbouj, Technische Universität München.
Recruitment status was:  Recruiting
First Posted : January 6, 2015
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Monther Bajbouj, Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Device: High resolution manometry (HRM) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry - Effect on Esophageal Motility of Standard Therapy.
Study Start Date : October 2013
Estimated Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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;

  2. 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

  3. Symptoms before/after therapy [ Time Frame: Two months ]
    Evaluation of symptoms via questionnaire before/after therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331849


Contacts
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Contact: Simon Nennstiel +49 89 4140 5055 simon.nennstiel@lrz.tum.de
Contact: Christoph Schlag +49 89 4140 5055 christoph.schlag@lrz.tum.de

Locations
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Germany
Klinikum rechts der Isar, II. Medizinische Klinik Recruiting
München, Germany, 81675
Contact: Simon Nennstiel    +40 89 4140 5055    simon.nennstiel@lrz.tum.de   
Sponsors and Collaborators
Technische Universität München
Investigators
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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

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Responsible Party: Monther Bajbouj, PD Dr. med., Technische Universität München
ClinicalTrials.gov Identifier: NCT02331849     History of Changes
Other Study ID Numbers: HIMEOS-2013
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015

Keywords provided by Monther Bajbouj, Technische Universität München:
Eosinophilic esophagitis (EoE)
GERD
esophageal motility

Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases