We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

New Serological Markers for Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01624129
Recruitment Status : Unknown
Verified February 2011 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
The purpose of the study is to investigate if serological parameters such as "extracellular Serum-Tryptase (ST)" and "eosinophilic cationic protein (ECP)" are useful for the diagnosis and surveillance of the eosinophilic esophagitis (EE).

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Drug: Fluticasone

Detailed Description:

The eosinophilic esophagitis (EE) is chronic inflammatory and immunological disease. The diagnosis of EE is based upon large numbers of eosinophils in the esophagus on histopathologic examination (> 20 eosinophils per high powered field in at least one specimen) despite acid suppression with a Proton-Pump-Inhibitor (PPI) for at least two weeks.

There are no diagnostic serological markers for EE so far, so that the purpose of the study is to investigate serological markers which are established in other allergic diseases.


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : January 2011


Group/Cohort Intervention/treatment
eosinophilic esophagitis
patients with histopathological defined eosinophilic esophagitis
Drug: Fluticasone
Guideline-based treatment with fluticasone 0,5 ml (1-0-1), step-up or step-down after 3 months based on the histopathological findings




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • histopathological defined eosinophilic esophagitis
  • Age: 18-80

Exclusion Criteria:

  • missing consent form
  • contraindications for performing esophagogastroscopy/taking biopsies of the esophagus

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): NCT01624129


Contacts
Contact: Monther Bajbouj, MD +49-89-41402450 monther.bajbouj@lrz.tum.de
Contact: Christoph Schlag, MD +49-89-41402450 Christoph.Schlag@lrz.tum.de

Locations
Germany
II. Medical Department, Technical University Munich Recruiting
Munich, Bavaria, Germany, 81675
Contact: Monther Bajbouj, MD    0049-89-41400    monther.bajbouj@lrz.tum.de   
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Monther Bajbouj, MD Technical University of Munich, 2nd Medical Department

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01624129     History of Changes
Other Study ID Numbers: 2011_0023
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: February 2011

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents