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OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
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)
Who can join
Ages 3 and older · All sexes
Full eligibility criteria
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)
About the study
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.
Sponsor: Children's Hospital Medical Center, Cincinnati · Participants: 1,350 · Started: Jul 17, 2015
Contact the study team
- Bliss Magella · Phone: 513-636-7832
Official record on ClinicalTrials.gov — NCT02523118
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.