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New Serological Markers for Eosinophilic Esophagitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Technische Universität München.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624129
First Posted: June 20, 2012
Last Update Posted: June 20, 2012
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.
Information provided by (Responsible Party):
Technische Universität München
February 8, 2011
June 20, 2012
June 20, 2012
January 2011
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No Changes Posted
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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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01624129
2011_0023
No
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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