Evaluating outcomes in eosinophilic gastrointestinal disorders
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)
This study is trying to find the best ways to measure how well people with eosinophilic gastrointestinal disorders are doing by looking at their symptoms and tissue samples over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1350 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 19 sites (Phoenix, Arizona and 18 other locations) |
| Trial ID | NCT02523118 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the best measures for assessing the health of individuals with eosinophilic gastrointestinal disorders (EGIDs) such as eosinophilic esophagitis, gastritis, gastroenteritis, and colitis. Participants aged 3 years and older will undergo routine endoscopies and/or colonoscopies, during which biopsies will be collected for analysis. The study will compare tissue samples with clinical symptoms and utilize standard questionnaires to evaluate patient well-being over time. Participants will be followed longitudinally to track changes in their condition and quality of life.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 3 years and older diagnosed with eosinophilic gastrointestinal disorders exhibiting specific eosinophil counts in tissue samples.
Not a fit: Patients with a history of intestinal surgery (other than G tube placement) or those with identifiable causes for eosinophilia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for monitoring and managing eosinophilic gastrointestinal disorders.
How similar studies have performed: Other studies have explored similar observational approaches in eosinophilic disorders, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Phoenix, Arizona and 18 other locations
- Mayo Clinic Hospital — Phoenix, Arizona, United States (Recruiting)
- Arkansas Children's Research Institute — Rogers, Arkansas, United States (Recruiting)
- Rady Children's Hospital — San Diego, California, United States (Recruiting)
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- Children's Hospital Colorado — Denver, Colorado, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Riley Children's Hospital — Indianapolis, Indiana, United States (Completed)
- National Institutes of Health (NIH) — Bethesda, Maryland, United States (Recruiting)
- Tufts University — Boston, Massachusetts, United States (Completed)
- Mayo Clinic — Rochester, Minnesota, United States (Completed)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Baylor College of Medicine & Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Marc E Rothenberg, MD, PhD — Cincinnati Children's Hospital Medical Center
- Study coordinator: Bliss Magella
- Email: bliss.magella@cchmc.org
- Phone: 513-636-7832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.