OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (NCT02523118) | Clinical Trial Compass
RecruitingNot Applicable
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
United States1,350 participantsStarted 2015-07-17
Plain-language 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.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since OMEGA is tracking mucosal eosinophilia across different parts of the GI tract, would my specific diagnosis — whether it's eosinophilic esophagitis, gastritis, or another form — affect whether participating in this study would be relevant for me?
2This study is listed as 'Phase NA,' which suggests it's an observational or registry-type study rather than a treatment trial — so would joining OMEGA change my actual treatment plan at all, or is it purely about collecting data on my condition over time?
3Given that the study is measuring eosinophil counts in tissue samples, would I need to undergo additional biopsies or endoscopies beyond what's already part of my standard care, and how does that affect the risks and burden of participating?
4Since this study spans 'across the ages' and covers multiple EGIDs, could the data my case contributes actually help researchers understand my specific condition better, or is my type of EGID less common in studies like this and therefore less likely to benefit me directly?
5Before considering this registry study, should I ask whether there are any active treatment trials for my specific EGID diagnosis that might be a higher priority to explore first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mucosal eosinophilia (eos/hpf)
Timeframe: Duration of funding, at least 10 years
Trial details
NCT IDNCT02523118
SponsorChildren's Hospital Medical Center, Cincinnati