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OMEGA: Understanding Eosinophilic Gastrointestinal Disorders

This study, called OMEGA, is looking for better ways to understand how people with eosinophilic gastrointestinal disorders (EGIDs) are doing. EGIDs include conditions like Eosinophilic Esophagitis (EoE), Eosinophilic Gastritis (EoG), Eosinophilic Gastroenteritis (EoN), and Eosinophilic Colitis (EoC). Researchers want to see if standard questionnaires about your symptoms and quality of life can accurately reflect what's happening in your body. If you join, you'll have tissue samples collected during your routine endoscopies or colonoscopies, and you'll fill out questionnaires over time. This study aims to enroll about 1350 people aged 3 years and older who have been diagnosed with an EGID based on specific levels of eosinophils (a type of white blood cell) in their digestive tract.

Study design
This is an observational study, meaning participants receive their usual care, and researchers collect information over time. It aims to include about 1350 participants.
What's involved
You would undergo routine endoscopies and/or colonoscopies, during which small tissue samples would be collected for the study. You would also complete questionnaires about your symptoms and quality of life at various times throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, mucosal eosinophilia, will be measured for at least 10 years, suggesting a long-term follow-up period.

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NCT02523118

OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Recruiting
Not specifiedAges 3+Observational
Children's Hospital Medical Center, Cincinnati
~1,350 participants
Updated 2025-09-12 on ClinicalTrials.gov

At a glance

Recruiting sites
16 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mucosal eosinophilia (eos/hpf)
Measured over Duration of funding, at least 10 years

Conditions

Eosinophilic Gastrointestinal Disorders (EGIDs)
Eosinophilic Esophagitis
Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic Colitis

Explore related trials

Eosinophilic ColitisEosinophilic EsophagitisEosinophilic GastritisEosinophilic Gastroenteritis

Where it's being run

19 sites across 16 states
Colorado2
Illinois2
Pennsylvania2
Arizona1
Arkansas1
California1
Indiana1
Maryland1

Study leadership

  • Marc E Rothenberg, MD, PhD · PRINCIPAL_INVESTIGATOR · Cincinnati Children's Hospital Medical Center

Who to contact

Bliss Magella
[email protected]
513-636-7832
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males or females 3 years of age and older
Mucosal eosinophilia:

Exclusion

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)

What this trial measures

  • Mucosal eosinophilia (eos/hpf)Duration of funding, at least 10 years

    Mucosal eosinophil levels are measured as eosinophils per high power field (eos/hpf). The primary outcome measure is to determine the change in mucosal eosinophil level (eos/hpf) and to determine if the change in mucosal eosinophil level in eos/hpf correlates with the change in scores on clinical outcome measure metrics.