OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

ID#: NCT02523118

Age: 3 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: July 01, 2015

End Date: January 01, 2051

Contact Information:
Kara Kliewer, PhD
513-636-4821
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, 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.
Eligibility:

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)
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