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OpenTrials
Completed

NCT Number: NCT02897271

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

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).

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Eosinophilic Colitis Eosinophilic Gastritis Eosinophilic Gastroenteritis Eosinophilic enteropathy Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Science, Little Rock, Arkansas, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mucosal eosinophilia (eos/hpf)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Office of Rare Diseases (ORD)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 13, 2016
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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