OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Recruiting

• Conditions: Eosinophilic Gastroenteritis; Eosinophilic Colitis; Eosinophilic Gastritis; Eosinophilic Esophagitis; Eosinophilic Gastrointestinal Disorders (EGIDs)

• Registration Number: NCT02523118
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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, EoG, EoN and EoC 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.

Detailed Description

This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EoG, EoN and EoC 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.

Study Timeline

• Study First Submitted: 2015-06-22
• Study Start: 2015-07-17
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2050-12-01
• Study Completion: 2051-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

• Males or females 3 years of age and older
• Mucosal eosinophilia:

EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus EoG ≥ 30 eosinophils/HPF in 5 HPF's in the body and/or antrum EoN ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum EoC ≥ 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mucosal eosinophilia (eos/hpf)	Duration of funding, at least 10 years	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.

Trial Locations

Locations (19)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Ann and Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Tufts University; 🇺🇸 Boston, Massachusetts, United States

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Baylor College of Medicine & Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Arkansas Children's Research Institute; 🇺🇸 Rogers, Arkansas, United States

Riley Children's Hospital; 🇺🇸 Indianapolis, Indiana, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital Colorado; 🇺🇸 Denver, Colorado, United States

Mayo Clinic Hospital; 🇺🇸 Phoenix, Arizona, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

National Institutes of Health (NIH); 🇺🇸 Bethesda, Maryland, United States

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States