OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
OMEGA
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 (EoG), Enteritis (EoN) and Colitis (EoC)
2 other identifiers
observational
1,350
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2015
CompletedStudy Start
First participant enrolled
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2050
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2051
September 12, 2025
August 1, 2025
35.4 years
June 22, 2015
September 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Males and females ages 3 or greater with EoE, EoG, EoN or EoC.
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Arkansas Children's Research Institute
Rogers, Arkansas, 72758, United States
Rady Children's Hospital
San Diego, California, 92123, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Children's Hospital Colorado
Denver, Colorado, 80218, United States
Northwestern University
Chicago, Illinois, 60208, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
National Institutes of Health (NIH)
Bethesda, Maryland, 20892, United States
Tufts University
Boston, Massachusetts, 02111, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor College of Medicine & Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Related Publications (1)
Safroneeva E, Pan Z, King E, Martin LJ, Collins MH, Yang GY, Capocelli KE, Arva NC, Abonia JP, Atkins D, Bonis PA, Dellon ES, Falk GW, Gonsalves N, Gupta SK, Hirano I, Leung J, Menard-Katcher PA, Mukkada VA, Schoepfer AM, Spergel JM, Wershil BK, Rothenberg ME, Aceves SS, Furuta GT; Consortium of Eosinophilic Gastrointestinal Disease Researchers. Long-Lasting Dissociation of Esophageal Eosinophilia and Symptoms After Dilation in Adults With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2022 Apr;20(4):766-775.e4. doi: 10.1016/j.cgh.2021.05.049. Epub 2021 May 29.
PMID: 34062314DERIVED
Related Links
Biospecimen
Biopsies from the gastrointestinal (GI) tract may be collected and used to learn more about eosinophilic gastrointestinal disorders. Genetic analysis may be performed on some of these samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc E Rothenberg, MD, PhD
Cincinnati Children's Hospital Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2015
First Posted
August 14, 2015
Study Start
July 17, 2015
Primary Completion (Estimated)
December 1, 2050
Study Completion (Estimated)
January 1, 2051
Last Updated
September 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share