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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02897271

Enrollment

381

Registered

2016-09-13

Start date

2016-08-31

Completion date

2020-05-31

Last updated

2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Colitis, Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Gastroenteritis

Keywords

Eosinophilic Gastrointestinal Disorders

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results