Recruiting

Observational StudyOMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT02523118

Conditions

Eosinophilic Gastrointestinal Disorders (EGIDs)

Eosinophilic Esophagitis

Eosinophilic Gastritis

Eosinophilic Gastroenteritis

Eosinophilic Colitis

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Eosinophilic Gastrointestinal Disorders (EGIDs)

Eosinophilic Esophagitis

Eosinophilic Gastritis

Eosinophilic Gastroenteritis

Eosinophilic Colitis

Study ID

NCT02523118

Start date

Jul 17, 2015

Status verified date

Aug, 2025

Completion date

Jan 1, 2051

Anticipated

Primary completion date

Dec 1, 2050

Anticipated

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

1350 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Mucosal eosinophilia (eos/hpf) [ Time Frame: Duration of funding, at least 10 years ]

Central Contacts and Locations

Central contacts

Bliss Magella

513-636-7832 bliss.magella@cchmc.org

Locations

Mayo Clinic Hospital

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Renee Nunez

480-301-4992 nunez.renee@mayo.edu

Principal Investigator:

Benjamin Wright, M.D.

Arkansas Children's Research Institute

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Allison Bruton

501-364-1060 CongletonAL@archildrens.org

Principal Investigator:

Robert Pesek, MD

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Kira Chaiboonma

(858)-966-1700 kchaiboonma@health.ucsd.edu

Principal Investigator:

Seema Aceves, M.D., PhD

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Keanna Capener

303-724-8974 keanna.capener@cuanschutz.edu

Principal Investigator:

Paul Menard-Katcher, MD

Children's Hospital Colorado

Recruiting

Denver, Colorado, United States, 80218

Contacts

Rachel Andrews

(720) 777-1994 rachel.andrews@childrenscolorado.org

Principal Investigator:

Glenn Furuta, M.D.

Northwestern University

Recruiting

Chicago, Illinois, United States, 60208

Contacts

Tenesha Thomas

tenesha.thomas@northwestern.edu

Principal Investigator:

Ikuo Hirano, M.D.

Ann and Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Mary Riordan

312-227-4558 mriordan@luriechildrens.org

Principal Investigator:

Joshua Wechsler, M.D.

National Institutes of Health (NIH)

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Perla Adames-Castillo

perla.adamescastillo@nih.gov

Principal Investigator:

Paneez Khoury, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Jaimie Gowatsky

212-241-4908 jaimie.gowatsky@mssm.edu

Principal Investigator:

Mirna Chehade, MD

University of North Carolina, Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Lucas Plott

919-966-8559 lucas_plott@med.unc.edu

Principal Investigator:

Evan Dellon, M.D., MPH

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Bliss Magella

513-636-7832 bliss.magella@cchmc.org

Principal Investigator:

Marc E. Rothenberg, MD, PhD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Ignacio De La Torre

215-590-6187 delatorrei@chop.edu

Principal Investigator:

Jonathan Spergel, MD, PhD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Lee

215-662-2493 Erin.Lee1@pennmedicine.upenn.edu

Maureen DeMarshall

215-349-8546 demarshm@mail.med.upenn.edu

Principal Investigator:

Kristle Lynch, M.D.

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Regina Tyree

(615) 343-6845 regina.n.tyree@vumc.org

Principal Investigator:

Girish Hiremath, MD, MPH

Baylor College of Medicine & Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Amanda Vega

832-824-0939 amandav@bcm.edu

Daisy Vita (Tran)

(832)-824-3640 dxtran1@texaschildrens.org

Principal Investigator:

Carla Davis, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Sophia Schuman

801-585-0894 sophia.schuman@hsc.utah.edu

Principal Investigator:

Kathryn Peterson, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 12, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-09-12.