Recruiting

Eosinophilic Esophagitis

Sponsor:

Insel Gruppe AG, University Hospital Bern

Code:

NCT00939263

Conditions

Deglutition Disorders

Esophageal Diseases

Eosinophilia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

assessment of disease activity using the EEsAI

Study Details

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.

Conditions

Deglutition Disorders

Esophageal Diseases

Eosinophilia

Study ID

NCT00939263

Start date

Jan, 2011

Status verified date

Sep, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

assessment of disease activity using the EEsAI

disease activity index

Primary outcome measure

  • Development of an EE Activity Index [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ekaterina Safroneeva, PhD

+41 31 631 59 71esafroneeva@ispm.unibe.ch

Claudia Kuehni, MD MSc, Prof.

+41 31 631 35 07kuehni@ispm.unibe.ch

Locations

Gastroenterology and Hepatology : Mayo Clinic, Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85261

Principal Investigator:

Pasha Fatima Shabana, MD

Department of Pediatrics : University of California

Recruiting

San Diego, California, United States, 92123

Principal Investigator:

Seema Aceves, MD PhD

The Children's Hospital : University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Glenn Furuta, MD

Gastroenterology and Hepatology : Mayo Clinic, Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

Sami R Achem, MD

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

Riley Hospital for Children : Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Sandeep Gupta, MD

Institute for Clinical Research and Health Policy Studies: Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02112

Principal Investigator:

John Leung, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States

Principal Investigator:

Yvonne Romero, MD

Pediatrics : Mount Sinai School of Medicine

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Mirna Chehade, MD MPH

Children's Hospital of Philadelphia : University of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Jonathan Spergel, MD, PhD

More Information

Sponsor

Insel Gruppe AG, University Hospital Bern

Last update posted

Sep 16, 2015

Last verified

Sep, 2015

Keywords

  • deglutition disorders
  • esophageal diseases
  • eosinophilia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern on 2015-09-16.