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

Completed

• Conditions: Eosinophilic Gastritis; Eosinophilic Esophagitis; Eosinophilic Gastroenteritis; Eosinophilic Colitis

• Registration Number: NCT02897271
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Primary Completion: 2019-09
• Study Completion: 2020-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mucosal eosinophilia (eos/hpf)	Duration of funding, approximately 5 years	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.

Trial Locations

Locations (6)

University of Arkansas for Medical Science; 🇺🇸 Little Rock, Arkansas, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, 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