OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Colitis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |