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New Serological Markers for Eosinophilic Esophagitis

Sponsor
Technische Universität München (Other)
Overall Status
Unknown status
CT.gov ID
NCT01624129
Collaborator
(none)
20
Enrollment
1
Location

Study Details

Study Description

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 Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Study Start Date :
Jan 1, 2011

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 II. Medical Department, Technical University Munich Munich Bavaria Germany 81675

    Sponsors and Collaborators

    • Technische Universität München

    Investigators

    • Principal Investigator: Monther Bajbouj, MD, Technical University of Munich, 2nd Medical Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Technische Universität München
    ClinicalTrials.gov Identifier:
    NCT01624129
    Other Study ID Numbers:
    • 2011_0023
    First Posted:
    Jun 20, 2012
    Last Update Posted:
    Jun 20, 2012
    Last Verified:
    Feb 1, 2011
    Additional relevant MeSH terms:
    Esophagitis
    Eosinophilic Esophagitis
    Fluticasone

    Study Results

    No Results Posted as of Jun 20, 2012