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

Status unconfirmed

Conditions studied: Deglutition Disorders, Esophageal Diseases, Eosinophilia

In brief

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.

Key facts

Study ID

NCT00939263

Run by

Insel Gruppe AG, University Hospital Bern

People needed

650

Starts

2011-01-01

Expected to finish

2016-12-01

Last updated by the study team

2015-09-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• every patient with the diagnosis Eosinophilic Esophagitis
• pediatric and adult EoE patients

Where it is running

• Gastroenterology and Hepatology : Mayo Clinic, Scottsdale — Scottsdale, Arizona, United States (enrolling)
• Department of Pediatrics : University of California — San Diego, California, United States (enrolling)
• The Children's Hospital : University of Colorado Denver — Aurora, Colorado, United States (enrolling)
• Gastroenterology and Hepatology : Mayo Clinic, Jacksonville — Jacksonville, Florida, United States (enrolling)
• Division of Gastroenterology : Northwestern University Chicago — Chicago, Illinois, United States (enrolling)
• Gastroenterology, hepatology and nutrition : Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Riley Hospital for Children : Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
• Institute for Clinical Research and Health Policy Studies: Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
• Pediatrics : Mount Sinai School of Medicine — New York, New York, United States (enrolling)
• Children's Hospital of Philadelphia : University of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Institute for Social and Preventive Medicine, University of Bern — Bern, Switzerland (enrolling)
• University Hospital Lausanne (CHUV) — Lausanne, Switzerland (enrolling)
• Department of Gastroenterology and Hepatology, Kantonsspital Lucerne — Lucerne, Switzerland (enrolling)
• Praxis Römerhof, Römerstr. 7, Olten — Olten, Switzerland (enrolling)
• Ste-Justine Hospital : University of Montreal — Montreal, Quebec, Canada
• Department of Gastroenterology, Inselspital/Bern University Hospital — Bern, Switzerland
• Pädiatrische Gastroenterologie Medizinische Universitäts-Kinderklinik Bern — Bern, Switzerland
• Division of Allergy and Inflammation : Harvard Medical School Boston — Brookline, Massachusetts, United States
• Institute for Pathology, Kantonsspital Lucerne — Lucerne, Switzerland
• Northumbria Healthcare Foundation Trust North Tyneside Hospital — North Shields, United Kingdom
• Gastroenterology, Hepatology and Nutrition : University of Cincinnati — Cincinnati, Ohio, United States
• Ostschweizer Kinderspital — Sankt Gallen, Switzerland
• Inova Fairfax Hospital for Children — Fairfax, Virginia, United States
• Clinical Epidemiology & Biostatistics : Mc Master University — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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