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

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ClinicalTrials.gov Identifier: NCT00939263
Recruitment Status : Unknown
Verified September 2015 by University Hospital Inselspital, Berne.
Recruitment status was:  Recruiting
First Posted : July 14, 2009
Last Update Posted : September 16, 2015
Sponsor:
Collaborators:
University of Bern
Kantonsspital Olten
Luzerner Kantonsspital
Mayo Clinic
University of Cincinnati
University of Colorado, Denver
Northwestern University
Indiana University School of Medicine
Philadelphia University
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
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 or disease Intervention/treatment
Deglutition Disorders Esophageal Diseases Eosinophilia Other: assessment of disease activity using the EEsAI

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 650 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Development of an EE Activity Index [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Evaluation and validation of the activity index [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

  Hide Study Locations
Locations
United States, Arizona
Gastroenterology and Hepatology : Mayo Clinic, Scottsdale Recruiting
Scottsdale, Arizona, United States, 85261
Principal Investigator: Pasha Fatima Shabana, MD         
United States, California
Department of Pediatrics : University of California Recruiting
San Diego, California, United States, 92123
Principal Investigator: Seema Aceves, MD PhD         
United States, Colorado
The Children`s Hospital : University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Glenn Furuta, MD         
United States, Florida
Gastroenterology and Hepatology : Mayo Clinic, Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Sami R Achem, MD         
United States, Illinois
Division of Gastroenterology : Northwestern University Chicago Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Ikuo Hirano, MD         
Gastroenterology, hepatology and nutrition : Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60614
Principal Investigator: Amir Kagalwalla, MD         
United States, Indiana
Riley Hospital for Children : Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Sandeep Gupta, MD         
United States, Massachusetts
Institute for Clinical Research and Health Policy Studies: Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02112
Principal Investigator: John Leung, MD         
Division of Allergy and Inflammation : Harvard Medical School Boston Not yet recruiting
Brookline, Massachusetts, United States, 02112
Principal Investigator: Javed Sheikh, MD         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States
Principal Investigator: Yvonne Romero, MD         
Sub-Investigator: Jeffrey Alexander, MD         
Sub-Investigator: Rayna Grothe, MD         
United States, New York
Pediatrics : Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Principal Investigator: Mirna Chehade, MD MPH         
United States, Ohio
Gastroenterology, Hepatology and Nutrition : University of Cincinnati Withdrawn
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children`s Hospital of Philadelphia : University of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Jonathan Spergel, MD, PhD         
United States, Virginia
Inova Fairfax Hospital for Children Not yet recruiting
Fairfax, Virginia, United States
Principal Investigator: Benjamin Enav, MD         
Sub-Investigator: Oral Alpan, MD         
Canada, Ontario
Clinical Epidemiology & Biostatistics : Mc Master University Not yet recruiting
Hamilton, Ontario, Canada
Principal Investigator: Paul Moayyedi, MD PhD         
Canada, Quebec
Ste-Justine Hospital : University of Montreal Not yet recruiting
Montréal, Quebec, Canada
Principal Investigator: Éric Drouin, MD         
Switzerland
Department of Gastroenterology, Inselspital/Bern University Hospital Withdrawn
Bern, Switzerland, 3010
Pädiatrische Gastroenterologie Medizinische Universitäts-Kinderklinik Bern Not yet recruiting
Bern, Switzerland, 3010
Principal Investigator: Susanne Schibli, MD         
Institute for Social and Preventive Medicine, University of Bern Recruiting
Bern, Switzerland, 3012
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   
Principal Investigator: Marcel Zwahlen, PhD, Prof.         
Principal Investigator: Claudia Kuehni, MD MSc, Prof.         
Sub-Investigator: Ekaterina Safroneeva, PhD         
University Hospital Lausanne (CHUV) Recruiting
Lausanne, Switzerland, 1011
Principal Investigator: Alain Schoepfer, MD, PD+MER1         
Department of Gastroenterology and Hepatology, Kantonsspital Lucerne Recruiting
Lucerne, Switzerland, 6000
Principal Investigator: Dominique Criblez         
Institute for Pathology, Kantonsspital Lucerne Not yet recruiting
Lucerne, Switzerland, 6000
Principal Investigator: Christian Bussmann, MD         
Praxis Römerhof, Römerstr. 7, Olten Recruiting
Olten, Switzerland, 4600
Principal Investigator: Alex Straumann, MD, Prof.         
Ostschweizer Kinderspital Not yet recruiting
St. Gallen, Switzerland, 9006
Principal Investigator: Pascal Mueller, MD         
United Kingdom
Northumbria Healthcare Foundation Trust North Tyneside Hospital Withdrawn
North Shields, United Kingdom
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Kantonsspital Olten
Luzerner Kantonsspital
Mayo Clinic
University of Cincinnati
University of Colorado, Denver
Northwestern University
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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00939263     History of Changes
Other Study ID Numbers: 231/08
0901 ( Other Identifier: Ethikkommision KiKli BE )
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015

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

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