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

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.

Conditions

• Deglutition Disorders
• Esophageal Diseases
• Eosinophilia

Interventions

OTHER

assessment of disease activity using the EEsAI

disease activity index

Sponsors & Collaborators

• University of Bern

  collaborator OTHER

• Kantonsspital Olten

  collaborator OTHER

• Luzerner Kantonsspital

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Indiana University School of Medicine

  collaborator OTHER

• Philadelphia University

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Alain Schoepfer, MD, PD+MER1 · Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois / CHUV

• Alex Straumann, MD, Prof. · Praxis Römerhof, Olten, Switzerland

• Marcel Zwahlen, PhD, Prof. · Institute for Social and Preventive Medicine, University of Bern

• Claudia Kuehni, MD MSc, Prof. · Institute for Social and Preventive Medicine, University of Bern

• Christian Bussmann, MD · Viollier AG

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2016-07-31

Completion

2016-12-31

Countries

• United States
• Canada
• Switzerland
• United Kingdom

Study Locations