OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages



Status:Recruiting
Conditions:Colitis, Gastrointestinal, Gastrointestinal, Digestive Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:3 - Any
Updated:1/12/2019
Start Date:July 2015
End Date:January 2051
Contact:Heidi Poppendeck, MPH
Email:heidi.poppendeck@cchmc.org
Phone:513-803-3078

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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) and Colitis (EC)

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 eosinophilic esophagitis (EoE),
eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or
colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected for
microscopic analysis. Treatments are then decided based on how the tissue looks. 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.

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

Inclusion Criteria:

- Males or females 3 years of age and older

- Mucosal eosinophilia (≥15 eos/hpf for EoE, ≥30 eos/hpf for EG, ≥32 eos/hpf for EC)

- Presence of symptoms is required for patients who are newly diagnosed but not required
for patients who were previously diagnosed

- EC patients must have a history of one of the following at the time of colonoscopy:

1. anemia

2. peripheral eosinophilia

3. hemoccult positive stool

4. EGID

5. allergic disease (allergic rhinitis, asthma, food allergy, eczema or other
allergic features suggestive of atopic disease)

Exclusion Criteria:

- History of intestinal surgery other than G tube placement

- Enrolled in a blinded investigational study

- 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)
We found this trial at
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Houston, Texas
Principal Investigator: Carla Davis, MD
Phone: 832-824-0939
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Evan Dellon, M.D., MPH
Phone: 919-843-0688
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-803-3078
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Jonathan Spergel, MD, PhD
Phone: 215-590-2549
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Kathryn Peterson, MD
Phone: 801-587-9050
University of Utah Research is a major component in the life of the U benefiting...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Paul Menard-Katcher, MD
Phone: 303-724-8974
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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9000 Rockville Pike
Bethesda, Maryland 20892
Principal Investigator: Paneez Khoury, MD
Phone: 301-402-5969
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Principal Investigator: John Leung, M.D.
Phone: 617-636-4941
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Ikuo Hirano, M.D.
Phone: 312-695-4036
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Barry Wershil, M.D.
Phone: 312-227-4546
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Denver, Colorado 80045
Principal Investigator: Glenn Furuta, M.D.
Phone: 720-777-5739
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Seema Aceves, M.D., PhD
Phone: 858-657-5131
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Mirna Chehade, MD
Phone: 212-241-8780
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4810 North Sheridan Road
Peoria, Illinois 61613
Principal Investigator: Sandeep Gupta, MD
Phone: 309-624-7552
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Gary Falk, M.D., MS
Phone: 215-349-8546
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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