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| Sponsors and Collaborators: |
University Hospital Inselspital, Berne Institute of Social and Preventive Medicine, University Bern Dept. of Gastroenterology, Kantonsspital Olten, Olten Institute for Pathology, Kantonsspital Lucerne, Lucerne Mayo Clinic Rochester, Minnesota, USA University of Cincinnati, Dpt of Pathology, USA University of Cincinnati, Dpt of Gastroenterology, USA University of Colorado Denver, School of Medicine, USA Northwestern University of Chicago, Illinois, USA Indiana University School of Medicine University of Philadelphia, Pennsylvania, USA and more |
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| Information provided by: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT00939263 |
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: | Cohort, Prospective |
| Official Title: | Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study |
| Estimated Enrollment: | 600 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
cohorts 1 (item weighting phase): 100 children with Eosinophilic Esophagitis, 100 adults with Eosinophilic Esophagitis
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Other: assessment of disease activity using the EEsAI
disease activity index
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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 |
Adult and pediatric patients with the diagnosis Eosinophilic Esophagitis, who are treated in the participating hospitals
Inclusion Criteria:
Contacts and Locations| Contact: Elisabeth Maurer, Dr. | 0041 631 35 25 | emaurer@ispm.unibe.ch |
| Contact: Claudia Kuehni, MD MSc, FMH (Paediatrics) | +41 31 631 35 07 | kuehni@ispm.unibe.ch |
| United States, Minnesota | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States | |
| Switzerland | |
| Institute for Social and Preventive Medicine, University of Bern | |
| Bern, Switzerland, 3012 | |
| Department of Gastroenterology, Inselspital/Bern University Hospital | |
| Bern, Switzerland, 3010 | |
| Pädiatrische Gastroenterologie Medizinische Universitäts-Kinderklinik Bern | |
| Bern, Switzerland, 3010 | |
| Institute for Pathology, Kantonsspital Lucerne | |
| Lucerne, Switzerland, 6000 | |
| Ostschweizer Kinderspital | |
| St. Gallen, Switzerland, 9006 | |
| Praxis Römerhof, Römerstr. 7, Olten | |
| Olten, Switzerland, 4600 | |
| Principal Investigator: | Alain Schoepfer, MD | Department of Gastroenterology, Inselspital/Bern University Hospital |
| 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, FMH (Paediatrics) | Institute for Social and Preventive Medicine, University of Bern |
| Study Director: | Christian Bussmann, MD | Institute for Pathology, Kantonsspital Lucerne |
More Information
| Responsible Party: | Dep. of Gastroenterology, Bern University Hospital, Bern; Farncombe Family Institute of Digestive Health Research McMaster University, Canada ( Alain Schoepfer MD ) |
| Study ID Numbers: | 231/08, 0901 (Ethikkommision KiKli BE) |
| Study First Received: | July 13, 2009 |
| Last Updated: | July 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00939263 History of Changes |
| Health Authority: | Switzerland: Ethikkommission |
|
deglutition disorders esophageal diseases eosinophilia |
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Otorhinolaryngologic Diseases Gastrointestinal Diseases Hematologic Diseases Leukocyte Disorders Eosinophilia Pharyngeal Diseases Eosinophilic Enteropathy |
Deglutition Disorders Esophagitis Digestive System Diseases Esophageal Disorder Esophageal Diseases Gastroenteritis |
|
Deglutition Disorders Esophagitis Otorhinolaryngologic Diseases Digestive System Diseases Hematologic Diseases Gastrointestinal Diseases |
Leukocyte Disorders Esophageal Diseases Gastroenteritis Pharyngeal Diseases Eosinophilia |
