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

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897271
• Other study ID #: 2016-4349
• Secondary ID: 5U54AI117804-03
• Status: Completed
• Start date: August 2016
• Est. completion date: May 2020

Study information

• Verified date: September 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Colitis
• Enteritis
• Eosinophilia
• Eosinophilic Colitis
• Eosinophilic Esophagitis
• Eosinophilic Gastritis
• Eosinophilic Gastroenteritis
• Esophagitis
• Gastritis
• Gastroenteritis

Locations

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

Sponsors (5)

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)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Rare Diseases Clinical Research Network website