Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort

Children's Hospital Medical Center, Cincinnati381 enrolled

Overview

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).

This retrospective chart review study will analyze the demographics, medical history, clinical features, and pathological data of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).

Study Type

OBSERVATIONAL

Enrollment

381

Conditions

Eosinophilic Esophagitis Eosinophilic Gastritis Eosinophilic Gastroenteritis Eosinophilic Colitis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (6)

University of Arkansas for Medical Science

Little Rock, Arkansas, United States

Children's Hospital Colorado

Denver, Colorado, United States

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Duration of funding, approximately 5 years

Data from ClinicalTrials.gov

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