NCT01624129

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

February 8, 2011

Last Update Submit

January 8, 2025

Conditions

Eosinophilic Esophagitis

Study Arms (1)

eosinophilic esophagitis

patients with histopathological defined eosinophilic esophagitis

Drug: Fluticasone

Interventions

FluticasoneDRUG

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • histopathological defined eosinophilic esophagitis
  • Age: 18-80

You may not qualify if:

  • missing consent form
  • contraindications for performing esophagogastroscopy/taking biopsies of the esophagus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

II. Medical Department, Technical University Munich

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24177377DERIVED

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Monther Bajbouj, MD

    Technical University of Munich, 2nd Medical Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monther Bajbouj, MD

CONTACT

+49-89-41402450monther.bajbouj@lrz.tum.de

Christoph Schlag, MD

CONTACT

+49-89-41402450Christoph.Schlag@lrz.tum.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2011

First Posted

June 20, 2012

Study Start

January 1, 2011

Primary Completion

October 1, 2012

Last Updated

January 9, 2025

Record last verified: 2013-01

Locations

DE(1)