OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Aug 12, 2015

Keywords

ClinConnect Summary

The OMEGA clinical trial is studying how to better understand and measure the health of people with eosinophilic gastrointestinal disorders (EGIDs), which include conditions like eosinophilic esophagitis and eosinophilic gastritis. The goal is to compare different ways of looking at tissue samples from patients to see how the presence of certain inflammatory cells relates to their symptoms. By using standard questionnaires, the researchers hope to find reliable ways to evaluate how well someone is doing with their condition.

To participate in this study, you need to be at least 3 years old and have a specific number of inflammatory cells in your gastrointestinal tissue. New patients must have symptoms, while those already diagnosed may not need to show symptoms. If you join the study, you can expect to undergo procedures like endoscopy or colonoscopy, where doctors will collect samples for analysis. This research is important because it aims to improve how we understand and treat eosinophilic disorders, ultimately helping patients feel better.

Gender

ALL

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., Ulcerative Colitis or Crohn\'s Disease)