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New Serological Markers for Eosinophilic Esophagitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Technische Universität München.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01624129
First received: February 8, 2011
Last updated: June 16, 2012
Last verified: February 2011
History of Changes
  Purpose

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 Intervention
Eosinophilic Esophagitis
 Drug: Fluticasone

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Estimated Enrollment: 20
Study Start Date: January 2011
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01624129     History of Changes
Other Study ID Numbers: 2011_0023
Study First Received: February 8, 2011
Last Updated: June 16, 2012
Health Authority: Germany: Ethics Commission

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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013