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

NCT ID: NCT02897271

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

381 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-05-31

Brief Summary

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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

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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).

Conditions

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Eosinophilic Esophagitis Eosinophilic Gastritis Eosinophilic Gastroenteritis Eosinophilic Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Office of Rare Diseases (ORD)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc E Rothenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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University of Arkansas for Medical Science

Little Rock, Arkansas, United States

Site Status

Children's Hospital Colorado

Denver, Colorado, United States

Site Status

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.rarediseasesnetwork.org/cms/CEGIR

Rare Diseases Clinical Research Network website

Other Identifiers

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5U54AI117804-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-4349

Identifier Type: -

Identifier Source: org_study_id

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