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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02897271
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital Medical Center, Cincinnati
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marc E Rothenberg, MD, PhD
Principal Investigator Affiliation Children's Hospital Medical Center, Cincinnati
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIHNIHNIHNIH
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis, Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Colitis
Study Website: View Trial Website
Additional Details

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Little Rock, Arkansas

Status

Address

University of Arkansas for Medical Science

Little Rock, Arkansas, 72205

Children's Hospital Colorado, Denver, Colorado

Status

Address

Children's Hospital Colorado

Denver, Colorado, 80218

Chapel Hill, North Carolina

Status

Address

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

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