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NCT02523118Recruiting

OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Children's Hospital Medical Center, Cincinnati

Start Date

7/17/2015

Completion Date

1/1/2051

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.

Detailed Description

This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EoG, EoN and EoC 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.

Eligibility Criteria

Age Range: 3 years to No maximum

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)

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Conditions

Eosinophilic Gastrointestinal Disorders (EGIDs)Eosinophilic EsophagitisEosinophilic GastritisEosinophilic GastroenteritisEosinophilic Colitis

Locations

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