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OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Key facts

Who runs it
Children's Hospital Medical Center, Cincinnati
Where
Aurora, Bethesda, Boston, Chapel Hill, Chicago, Cincinnati, Denver, Houston, Indianapolis, Nashville, New York, Philadelphia, Phoenix, Rochester, Rogers, Salt Lake City, and San Diego, United StatesSee the 19 sites
Trial code
Status
Recruiting
People taking part
1,350 people, planned
Started
17 Jul 2015
Expected to end
1 Jan 2051
Type of study
Observational
Record updated
12 September 2025

Who can take part

Age
3 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • History of intestinal surgery other than G tube placement
  • 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)
  • Enrolled in a blinded investigational study at the time of the first study visit
  • Have esophageal stricture (\<3mm)

Where in United States

  • University of Colorado DenverAurora, United StatesContact: Keanna CapenerTaking people
  • National Institutes of Health (NIH)Bethesda, United StatesContact: Perla Adames-CastilloTaking people
  • Tufts UniversityBoston, United StatesContact: Bliss MagellaNo longer taking part
  • University of North Carolina, Chapel HillChapel Hill, United StatesContact: Lucas PlottTaking people
  • Ann and Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesContact: Mary RiordanTaking people
  • Northwestern UniversityChicago, United StatesContact: Tenesha ThomasTaking people
  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Bliss MagellaTaking people
  • Children's Hospital ColoradoDenver, United StatesContact: Rachel AndrewsTaking people
  • Baylor College of Medicine/ Texas Children's HospitalHouston, United StatesContact: Amanda VegaTaking people
  • Riley Children's HospitalIndianapolis, United StatesContact: Bliss MagellaNo longer taking part
  • Vanderbilt University Medical CenterNashville, United StatesContact: Regina TyreeTaking people
  • Icahn School of Medicine at Mount SinaiNew York, United StatesContact: Jaimie GowatskyTaking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Ignacio De La TorreTaking people
  • University of PennsylvaniaPhiladelphia, United StatesContact: Erin LeeTaking people
  • Mayo Clinic HospitalPhoenix, United StatesContact: Renee NunezTaking people
  • Mayo ClinicRochester, United StatesContact: Bliss MagellaNo longer taking part
  • Arkansas Children's Research InstituteRogers, United StatesContact: Allison BrutonTaking people
  • University of UtahSalt Lake City, United StatesContact: Sophia SchumanTaking people
  • Rady Children's HospitalSan Diego, United StatesContact: Kira ChaiboonmaTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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 (EoG), Enteritis (EoN) and Colitis (EoC)
Record updated
12 September 2025