New Serological Markers for Eosinophilic Esophagitis

NCT ID: NCT01624129

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Eosinophilic Esophagitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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eosinophilic esophagitis

patients with histopathological defined eosinophilic esophagitis

Fluticasone

Intervention Type DRUG

Guideline-based treatment with fluticasone 0,5 ml (1-0-1), step-up or step-down after 3 months based on the histopathological findings

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monther Bajbouj, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich, 2nd Medical Department

Locations

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II. Medical Department, Technical University Munich

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Monther Bajbouj, MD

Role: CONTACT

+49-89-41402450

Christoph Schlag, MD

Role: CONTACT

+49-89-41402450

Facility Contacts

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Monther Bajbouj, MD

Role: primary

0049-89-41400

References

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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.

Reference Type DERIVED
PMID: 24177377 (View on PubMed)

Other Identifiers

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2011_0023

Identifier Type: -

Identifier Source: org_study_id

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