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

NCT02897271 | Completed DMC

• 2 other identifiers: 2016-43495U54AI117804-03
• Study Type: observational
• Target: 381
• Locations: 1 country
• Sites: 6

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).

Conditions

Eosinophilic Esophagitis; Eosinophilic Gastritis; Eosinophilic Gastroenteritis; Eosinophilic Colitis

Keywords

Eosinophilic Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female patients of any age with a diagnosis of eosinophilic gastrointestinal disorder (EGID) other than eosinophilic esophagitis (EoE) alone, including eosinophilic gastritis (EG), eosinophilic gastroenteritis (EGE), and eosinophilic colitis (EC).

You may qualify if:

• 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.

You may not qualify if:

• Gastrointestinal eosinophilia caused by another disorder.
• Diagnosis of EoE without another EGID.
• Insufficient medical record or pathology data available to support an EGID diagnosis.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Office of Rare Diseases (ORD): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (6)

University of Arkansas for Medical Science

Little Rock, Arkansas, 72205, United States

Location

Children's Hospital Colorado

Denver, Colorado, 80218, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Rare Diseases Clinical Research Network website

MeSH Terms

Conditions

Eosinophilic Esophagitis; Eosinophilic enteropathy

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marc E Rothenberg, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 13, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: May 1, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

US (6)