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NCT01624129 Clinical Trial

New Serological Markers for Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01624129
Other study ID # 2011_0023
Secondary ID
Status Recruiting
Phase N/A
First received February 8, 2011
Last updated June 16, 2012
Start date January 2011

Study information
Verified date February 2011
Source Technische Universität München
Contact Monther Bajbouj, MD
Phone +49-89-41402450
Email monther.bajbouj@lrz.tum.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- histopathological defined eosinophilic esophagitis

- Age: 18-80

Exclusion Criteria:

- missing consent form

- contraindications for performing esophagogastroscopy/taking biopsies of the esophagus

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany II. Medical Department, Technical University Munich Munich Bavaria

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

See also
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