OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Recruiting now
Conditions studied: Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Colitis
In brief
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.
Key facts
- Study ID
- NCT02523118
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 1350
- Starts
- 2015-07-17
- Expected to finish
- 2051-01-01
- Last updated by the study team
- 2025-09-12
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
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)
Where it is running
- Mayo Clinic Hospital — Phoenix, Arizona, United States (enrolling)
- Arkansas Children's Research Institute — Rogers, Arkansas, United States (enrolling)
- Rady Children's Hospital — San Diego, California, United States (enrolling)
- University of Colorado Denver — Aurora, Colorado, United States (enrolling)
- Children's Hospital Colorado — Denver, Colorado, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Baylor College of Medicine & Texas Children's Hospital — Houston, Texas, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
- National Institutes of Health (NIH) — Bethesda, Maryland, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
- University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Riley Children's Hospital — Indianapolis, Indiana, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Tufts University — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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