Eosinophilic Gastrointestinal Disorders Registry

March 16, 2026 updated by: Joshua Wechsler, Ann & Robert H Lurie Children's Hospital of Chicago

The purpose of this study is to learn more about Eosinophilic Gastrointestinal Disorders (EGIDs). With this registry we hope to find out more about the symptoms that patients have during their treatment, the quality of life they have with the diagnosis, what the disease looks like throughout the different treatment methods, and if there is a connection between EGIDs and connective tissue disorders.

The goal of this study is to be able to better understand EGIDs and use information gained from all the information collected on this study for more precise treatments in the future. We want to create a large collection of samples, called a biorepository, to learn the most about EGIDs as possible. When the samples are collected, which will occur at procedures directed by your child's doctor as part of their standard of care, they will be stored for an unlimited amount of time to perform experiments on these samples and to gather information about EGIDs

Study Overview

Status

Recruiting

Conditions

Detailed Description

Eosinophilic gastrointestinal disorders (EGIDs) comprise a family of disorders that includes Eosinophilic Esophagitis (EoE), Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC). The natural history of EGIDs is not well characterized. The aim of this registry is to create a comprehensive prospective database of EGID patients as a foundation towards an improved understanding of disease progression and pathophysiologic mechanism. There is a critical need to understand the relationship between disease mechanism, treatment response, measurements of disease severity, and noninvasive disease activity monitoring strategies. Characterization of the spectrum of clinical phenotype of EGIDs is important in the search for novel pathogenic molecules/pathways to inform targeted treatment strategies.

This study proposes to establish an EGID patient registry comprised of data collected from patients at Lurie Children's Hospital of Chicago undergoing standard of care evaluation, diagnosis, and treatment for EGIDs. The registry aims to characterize the clinical phenotype of EGIDs by examining (1) clinical, endoscopic, and histologic characteristics of EGID patients compared to non-EGID controls; (2) clinical, endoscopic, and histologic response of EGID patients to treatment; (3) functional assessment of the esophagus in patients undergoing evaluation for and with established diagnosis of EoE; (4) patient-reported quality of life and symptom scales; (5) the association of EGIDs with inherited Connective Tissue Disorders (CTDs) and dysautonomia, and (6) cellular and molecular biomarkers of disease severity. Our aim is to perform a prospective analysis of all EoE, EG, EGE, and EC patients, as well as patients suspected of having an EGID evaluated at Lurie Children's Hospital. Patients who are suspected of having an EGID and those with an established diagnosis of an EGID will be approached for recruitment into the registry.

The data and samples collected during this study are important to this study and to future research related to EGIDs. The data and samples will be used as indicated within this protocol and remaining samples and data will be stored and kept for future research studies on gastrointestinal diseases.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H Lurie Children's Hospital of Chicago
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joshua B Wechsler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 25 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The subjects of this study include patients followed at Lurie Children's Hospital for evaluation or treatment of an EGID. Patients receiving care at Lurie Children's hospital include residents of the greater Chicago area, as well as patients throughout the Midwest seeking care at a tertiary referral center. Patients suspected of having EGID present with a wide variety of symptoms, ranging from classic symptoms of EoE including dysphagia and food impaction, to more general symptoms of abdominal pain, heartburn, vomiting, food refusal, failure to thrive, and diarrhea. Diagnostic criteria for EGIDs rely on clinical symptoms and the presence of eosinophil-predominant inflammation on biopsy.

Description

Inclusion Criteria:

  • Patients with an established diagnosis of an EGID, based on pathology findings from an endoscopy or colonoscopy with biopsies.
  • Patients suspected of having an EGID and undergoing endoscopic evaluation for further assessment

Exclusion Criteria:

  • Patients who do not consent to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical/Patient-Reported Measures
Time Frame: through study completion, an average of 6 months to 1 year
Families complete questionnaires regarding reported symptoms and quality of life as well as family history, patient history and dietary checklists. Change in responses will be assessed at collection timepoints
through study completion, an average of 6 months to 1 year
Endoscopic measures
Time Frame: through study completion, an average of 6 months to 1 year
Endoscopy visual findings will be evaluated using EREFS measurements, which measure the visual findings of Exudates, Rings, Edema, Furrows, and Strictures
through study completion, an average of 6 months to 1 year
Physical exam findings
Time Frame: through study completion, an average of 6 months to 1 year
hypermobility as assessed by Beighton Score, assessed from 5 questions on a 0-2 scale with a higher score reporting a positive association with hypermobility
through study completion, an average of 6 months to 1 year
Histologic features
Time Frame: through study completion, an average of 6 months to 1 year
Histology markers of eosinophilic esophagitis, specifically eos/hpf, will be assessed at standard of care endoscopies to show change throughout study participation
through study completion, an average of 6 months to 1 year
Molecular measures
Time Frame: through study completion, an average of 6 months to 1 year
In particular, we will assess mast cells and t-cells, and their mediators that are increased in EGIDs
through study completion, an average of 6 months to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Joshua B Wechsler, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-3601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eosinophilic Gastroenteritis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe