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CompletedNCT02897271Updated Sep 28, 2021

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

An observational study in Eosinophilic Esophagitis, Eosinophilic Gastritis and Eosinophilic Gastroenteritis, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 6 sites in United States. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by Children's Hospital Medical Center, Cincinnati · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
381
Sex
All
01

Study 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).

Read the detailed 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).

02

Conditions studied

  • Eosinophilic Esophagitis
  • Eosinophilic Gastritis
  • Eosinophilic Gastroenteritis
  • Eosinophilic Colitis

Keywords

  • Eosinophilic Gastrointestinal Disorders
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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.
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
381 participants (actual)
Patient registry
No
05

What researchers measure

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.

    Time frame: Duration of funding, approximately 5 years

06

Study locations

6 sites
  • University of Arkansas for Medical Science
    Little Rock, Arkansas 72205, United States
  • Children's Hospital Colorado
    Denver, Colorado 80218, United States
  • University of North Carolina, Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT02897271
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)
Responsible party
Sponsor
First posted
Sep 13, 2016
Start date
Aug 2016
Primary completion
Sep 2019
Completion
May 2020
Last update
Sep 28, 2021

Study contacts

Marc E Rothenberg, MD, PhD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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