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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02897271
Other study ID # 2016-4349
Secondary ID 5U54AI117804-03
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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