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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

February 8, 2011
June 16, 2012
January 2011
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Complete list of historical versions of study NCT01624129 on ClinicalTrials.gov Archive Site
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New Serological Markers for Eosinophilic Esophagitis
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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).

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

primary care clinic

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
eosinophilic esophagitis
patients with histopathological defined eosinophilic esophagitis
Intervention: Drug: Fluticasone
Schlag C, Pfefferkorn S, Brockow K, Haller B, Slotta-Huspenia J, Schulz S, von Werder A, Ring J, Schmid RM, Bajbouj M. Serum eosinophil cationic protein is superior to mast cell tryptase as marker for response to topical corticosteroid therapy in eosinophilic esophagitis. J Clin Gastroenterol. 2014 Aug;48(7):600-6. doi: 10.1097/01.mcg.0000436439.67768.8d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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Inclusion Criteria:

  • histopathological defined eosinophilic esophagitis
  • Age: 18-80

Exclusion Criteria:

  • missing consent form
  • contraindications for performing esophagogastroscopy/taking biopsies of the esophagus
Both
18 Years to 80 Years
No
Contact: Monther Bajbouj, MD +49-89-41402450 monther.bajbouj@lrz.tum.de
Contact: Christoph Schlag, MD +49-89-41402450 Christoph.Schlag@lrz.tum.de
Germany
 
NCT01624129
2011_0023
No
Technische Universität München
Technische Universität München
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Principal Investigator: Monther Bajbouj, MD Technical University of Munich, 2nd Medical Department
Technische Universität München
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP