Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study

Status: Unknown status
Location: See all (25) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• every patient with the diagnosis Eosinophilic Esophagitis

• pediatric and adult EoE patients

Locations
United States
Arizona
Gastroenterology and Hepatology : Mayo Clinic, Scottsdale
Recruiting
Scottsdale
California
Department of Pediatrics : University of California
Recruiting
San Diego
Colorado
The Children's Hospital : University of Colorado Denver
Recruiting
Aurora
Florida
Gastroenterology and Hepatology : Mayo Clinic, Jacksonville
Recruiting
Jacksonville
Illinois
Division of Gastroenterology : Northwestern University Chicago
Recruiting
Chicago
Gastroenterology, hepatology and nutrition : Ann & Robert H. Lurie Children's Hospital of Chicago
Recruiting
Chicago
Indiana
Riley Hospital for Children : Indiana University School of Medicine
Recruiting
Indianapolis
Massachusetts
Institute for Clinical Research and Health Policy Studies: Tufts Medical Center
Recruiting
Boston
Division of Allergy and Inflammation : Harvard Medical School Boston
Not yet recruiting
Brookline
Minnesota
Mayo Clinic Rochester
Recruiting
Rochester
New York
Pediatrics : Mount Sinai School of Medicine
Recruiting
New York
Ohio
Gastroenterology, Hepatology and Nutrition : University of Cincinnati
Withdrawn
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia : University of Philadelphia
Recruiting
Philadelphia
Virginia
Inova Fairfax Hospital for Children
Not yet recruiting
Fairfax
Other Locations
Canada
Clinical Epidemiology & Biostatistics : Mc Master University
Not yet recruiting
Hamilton
Ste-Justine Hospital : University of Montreal
Not yet recruiting
Montréal
Switzerland
Department of Gastroenterology, Inselspital/Bern University Hospital
Withdrawn
Bern
Institute for Social and Preventive Medicine, University of Bern
Recruiting
Bern
Pädiatrische Gastroenterologie Medizinische Universitäts-Kinderklinik Bern
Not yet recruiting
Bern
University Hospital Lausanne (CHUV)
Recruiting
Lausanne
Department of Gastroenterology and Hepatology, Kantonsspital Lucerne
Recruiting
Lucerne
Institute for Pathology, Kantonsspital Lucerne
Not yet recruiting
Lucerne
Praxis Römerhof, Römerstr. 7, Olten
Recruiting
Olten
Ostschweizer Kinderspital
Not yet recruiting
St. Gallen
United Kingdom
Northumbria Healthcare Foundation Trust North Tyneside Hospital
Withdrawn
North Shields
Contact Information
Primary
Ekaterina Safroneeva, PhD
esafroneeva@ispm.unibe.ch
+41 31 631 59 71
Backup
Claudia Kuehni, MD MSc, Prof.
kuehni@ispm.unibe.ch
+41 31 631 35 07
Time Frame
Start Date: January 2011
Completion Date: December 2016
Participants
Target number of participants: 650
Treatments
1
cohorts 1 (item weighting phase): 100 children with Eosinophilic Esophagitis, 150 adults with Eosinophilic Esophagitis
2
cohorts 2 (evaluation phase): 200 children with Eosinophilic Esophagitis, 200 adults with Eosinophilic Esophagitis
Sponsors
Collaborators: Mayo Clinic, University of Cincinnati, Luzerner Kantonsspital, Northwestern University, Indiana University School of Medicine, University of Bern, University of Colorado, Denver, Kantonsspital Olten, Philadelphia University
Leads: University Hospital Inselspital, Berne

This content was sourced from clinicaltrials.gov

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