NCT02523118 OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
| NCT ID | NCT02523118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Eosinophilic Gastrointestinal Disorders (EGIDs) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,350 participants |
| Start Date | 2015-07-17 |
| Primary Completion | 2050-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,350 participants in total. It began in 2015-07-17 with a primary completion date of 2050-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.,
Frequently Asked Questions
Who can join the NCT02523118 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying Eosinophilic Gastrointestinal Disorders (EGIDs). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02523118 currently recruiting?
Yes, NCT02523118 is actively recruiting participants. Visit ClinicalTrials.gov or contact Children's Hospital Medical Center, Cincinnati to inquire about joining.
Where is the NCT02523118 trial being conducted?
This trial is being conducted at Phoenix, United States, Rogers, United States, San Diego, United States, Aurora, United States and 1 additional location.
Who is sponsoring the NCT02523118 clinical trial?
NCT02523118 is sponsored by Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 1,350 participants.