Eosinophilic Esophagitis Clinical Trial
Official title:
Demographics, Clinical Characteristics, and Pathology of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort
Verified date | September 2021 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to investigate features of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).
Status | Completed |
Enrollment | 381 |
Est. completion date | May 2020 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Diagnosis of an EGID including EG, EGE, and/or EC. Subjects with EoE can be included if they also have another EGID. - Clinical symptoms of gastrointestinal dysfunction. - Findings of increased eosinophils on tissue biopsy at the time of diagnosis, before treatment initiated. - Exclusion of other causes of gastrointestinal eosinophilia. Exclusion Criteria: - Gastrointestinal eosinophilia caused by another disorder. - Diagnosis of EoE without another EGID. - Insufficient medical record or pathology data available to support an EGID diagnosis. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina, Chapel Hill | Chapel Hill | North Carolina |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Children's Hospital Colorado | Denver | Colorado |
United States | University of Arkansas for Medical Science | Little Rock | Arkansas |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | National Center for Advancing Translational Science (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases (ORD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mucosal eosinophilia (eos/hpf) | 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 other measures of disease activity. | Duration of funding, approximately 5 years |
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