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Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index (EEsAI)

This study is currently recruiting participants.
Verified February 2013 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
University of Bern
Dept. of Gastroenterology, Kantonsspital Olten, Olten
Luzerner Kantonsspital
Mayo Clinic Rochester, Minnesota, USA
University of Cincinnati
University of Colorado, Denver
Northwestern University of Chicago, Illinois, USA
Indiana University School of Medicine
Philadelphia University
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00939263
First received: July 13, 2009
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting children and adults. The most frequent symptoms are swallowing difficulties and thoracic pain. The disease has first been described in the 1980s and is found with rapidly increasing frequency mainly in industrialized countries. The factors that lead to EoE are until now incompletely understood, of importance, the disease is found more frequently in men and patients suffering from allergic diseases (e.g., Asthma). So far there exists no activity index to define the severity of EoE; such an index is urgently needed for future clinical trials to determine the efficacy of current and future therapies. The investigators' 3-year project, carried out in cooperation with international EoE experts, aims at the development of an activity index for adult and pediatric EoE patients that will be used in future clinical trials as well as observational studies.


Condition Intervention
Deglutition Disorders
Esophageal Diseases
Eosinophilia
 Other: assessment of disease activity using the EEsAI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Development of an EE Activity Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation and validation of the activity index [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
cohorts 1 (item weighting phase): 100 children with Eosinophilic Esophagitis, 150 adults with Eosinophilic Esophagitis
 Other: assessment of disease activity using the EEsAI
disease activity index
2
cohorts 2 (evaluation phase): 200 children with Eosinophilic Esophagitis, 200 adults with Eosinophilic Esophagitis
 Other: assessment of disease activity using the EEsAI
disease activity index

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult and pediatric patients with the diagnosis Eosinophilic Esophagitis, who are treated in the participating hospitals

Criteria

Inclusion Criteria:

  • every patient with the diagnosis Eosinophilic Esophagitis
  • pediatric and adult EoE patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939263

Contacts
Contact: Ekaterina Safroneeva, PhD +41 31 631 59 71 esafroneeva@ispm.unibe.ch
Contact: Claudia Kuehni, MD MSc, Prof. +41 31 631 35 07 kuehni@ispm.unibe.ch

  Show 25 Study Locations
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Dept. of Gastroenterology, Kantonsspital Olten, Olten
Luzerner Kantonsspital
Mayo Clinic Rochester, Minnesota, USA
University of Cincinnati
University of Colorado, Denver
Northwestern University of Chicago, Illinois, USA
Indiana University School of Medicine
Philadelphia University
Investigators
Principal Investigator: Alain Schoepfer, MD, PD+MER1 Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois / CHUV
Study Chair: Alex Straumann, MD, Prof. Praxis Römerhof, Olten, Switzerland
Study Director: Marcel Zwahlen, PhD, Prof. Institute for Social and Preventive Medicine, University of Bern
Study Director: Claudia Kuehni, MD MSc, Prof. Institute for Social and Preventive Medicine, University of Bern
Study Director: Christian Bussmann, MD Viollier AG
  More Information

Publications:

Responsible Party: Alain Schoepfer MD, Centre Hospitalier Universitaire Vaudois / CHUV
ClinicalTrials.gov Identifier: NCT00939263     History of Changes
Other Study ID Numbers: 231/08, 0901 (Ethikkommision KiKli BE)
Study First Received: July 13, 2009
Last Updated: February 22, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
deglutition disorders
esophageal diseases
eosinophilia

Additional relevant MeSH terms:
Deglutition Disorders
Eosinophilia
Esophageal Diseases
Esophagitis
Eosinophilic Esophagitis
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
 Otorhinolaryngologic Diseases
Leukocyte Disorders
Hematologic Diseases
Gastroenteritis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013