OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Eosinophilic Esophagitis Clinical Trial

— OMEGA  

Official title:

A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients With Eosinophilic Esophagitis (EoE), Gastritis (EG), Gastroenteritis (EGE) and Colitis (EC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02523118
• Other study ID #: 2015-2311
• Secondary ID: U54AI117870
• Status: Recruiting
• Start date: July 17, 2015
• Est. completion date: January 1, 2051

Study information

• Verified date: December 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Kara Kliewer, PhD
• Phone: 513-636-4821
• Email: Kara.kliewer[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EG, EGE and EC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.

Description:

This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EG, EGE and EC will be followed over the course of time to see if standard questionnaires can give us an idea of how well the person is doing.

Participants undergoing standard of care (normal, routine care) endoscopies and/or colonoscopies will have biopsies (small pieces of tissue from the GI tract normally collected during these procedures) collected and used for the research study. Participants will also complete questionnaires related to their symptoms and quality of life. Participants will be followed over the course of time and asked to complete the questionnaires at various time points throughout the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: January 1, 2051
• Est. primary completion date: December 1, 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Males or females 3 years of age and older

• Mucosal eosinophilia: EoE = 15 eosinophils/HPF in the distal or proximal esophagus, EG = 30 eosinophils/HPF in 5 HPF's in the body and/or antrum, EGE = 53 eosinophils/HPF in the duodenum and/or = 56 eosinophils/HPF in the jejunum and/or ileum, EC = 84 eosinophils/HPF from the transverse or descending colon and/or = 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with = 100 eosinophils/HPF

• Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed.

Exclusion Criteria:

• History of intestinal surgery other than G tube placement

• Enrolled in a blinded investigational study at the time of the first study visit

• Have esophageal stricture (<3mm)

• Have other identifiable causes for eosinophilia (except Inflammatory Bowel Disease):

infections, Gastrointestinal (GI) cancer, other GI inflammatory disease (e.g., Ulcerative Colitis or Crohn's Disease)

Related Conditions & MeSH terms

• Colitis
• Digestive System Diseases
• Enteritis
• Eosinophilia
• Eosinophilic Colitis
• Eosinophilic Esophagitis
• Eosinophilic Gastritis
• Eosinophilic Gastroenteritis
• Eosinophilic Gastrointestinal Disorders (EGIDs)
• Esophagitis
• Gastritis
• Gastroenteritis
• Gastrointestinal Diseases

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	National Institutes of Health (NIH)	Bethesda	Maryland
United States	Tufts University	Boston	Massachusetts
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Ann and Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Hospital Colorado	Denver	Colorado
United States	Baylor College of Medicine & Texas Children's Hospital	Houston	Texas
United States	Riley Children's Hospital	Indianapolis	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Arkansas Children's Research Institute	Rogers	Arkansas
United States	University of Utah	Salt Lake City	Utah
United States	Rady Children's Hospital	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Center for Advancing Translational Sciences (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), ORDR

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal eosinophilia (eos/hpf)	Mucosal eosinophil levels are measured as eosinophils per high power field (eos/hpf). The primary outcome measure is to determine the change in mucosal eosinophil level (eos/hpf) and to determine if the change in mucosal eosinophil level in eos/hpf correlates with the change in scores on clinical outcome measure metrics.	Duration of funding, at least 10 years

External Links

•   Learn more about CEGIR at this website.