Summary

for people ages 3-65 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected for microscopic analysis. Treatments are then decided based on how the tissue looks. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.

Official Title

A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients With Eosinophilic Esophagitis (EoE), Gastritis (EG) and Colitis (EC)

Details

This is a longitudinal observational study in which individuals (males and females between the ages of 3-65 years) with EoE, EG, and EC will be followed over the course of time to see if standard questionnaires can give us an idea of how well the person is doing.

Participants undergoing standard of care (normal, routine care) endoscopies and/or colonoscopies will have biopsies (small pieces of tissue from the GI tract normally collected during these procedures) collected and used for the research study. Participants will also complete questionnaires related to their symptoms and quality of life. Participants will be followed over the course of time and asked to complete the questionnaires at various time points throughout the study.

Keywords

Eosinophilic Gastrointestinal Disorders (EGIDs) Eosinophilic Esophagitis Eosinophilic Gastritis Eosinophilic Colitis Colitis Esophagitis Gastritis Digestive System Diseases Gastrointestinal Diseases

Eligibility

You can join if…

Open to people ages 3-65

  • Males or females between 3-65 years of age
  • Presence of symptoms
  • Mucosal eosinophilia (≥15 eos/hpf for EoE, ≥30 eos/hpf for EG, ≥65 eos/hpf for EC)

You CAN'T join if...

  • History of intestinal surgery
  • Enrolled in a blinded investigational study
  • Have esophageal stricture (<3mm)
  • Have other identifiable causes for eosinophilia, infections, Gastrointestinal (GI)cancer, other GI inflammatory disease

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • Children's Hospital Colorado accepting new patients
    Denver Colorado 80218 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati
Links
https://www.rarediseasesnetwork.org/cms/CEGIR
ID
NCT02523118
Study Type
Observational
Last Updated
January 2017