Actively Recruiting
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-09-12
1350
Participants Needed
19
Research Sites
1850 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females 3 years of age and older
- Mucosal eosinophilia as defined by: EoE 65 15 eosinophils/HPF in the distal or proximal esophagus
- EoG 65 30 eosinophils/HPF in 5 HPFs in the body and/or antrum
- EoN 65 53 eosinophils/HPF in the duodenum and/or 65 56 eosinophils/HPF in the jejunum and/or ileum
- EoC 65 84 eosinophils/HPF from the transverse or descending colon and/or 65 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with 65 100 eosinophils/HPF
- Presence of symptoms is required for newly diagnosed patients but not for previously diagnosed patients
You will not qualify if you...
- History of intestinal surgery other than G tube placement
- Currently enrolled in a blinded investigational study at the time of the first study visit
- Presence of esophageal stricture less than 3 millimeters
- Other identifiable causes for eosinophilia except inflammatory bowel disease, such as infections, gastrointestinal cancer, or other gastrointestinal inflammatory diseases like ulcerative colitis or Crohn's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Arkansas Children's Research Institute
Rogers, Arkansas, United States, 72758
Actively Recruiting
3
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
4
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Children's Hospital Colorado
Denver, Colorado, United States, 80218
Actively Recruiting
6
Northwestern University
Chicago, Illinois, United States, 60208
Actively Recruiting
7
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
8
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
Completed
9
National Institutes of Health (NIH)
Bethesda, Maryland, United States, 20892
Actively Recruiting
10
Tufts University
Boston, Massachusetts, United States, 02111
Completed
11
Mayo Clinic
Rochester, Minnesota, United States, 55902
Completed
12
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
13
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
14
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
15
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
17
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
18
Baylor College of Medicine & Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
19
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
B
Bliss Magella
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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