Clinical Trial on Esophagitis, Eosinophilic Esophagitis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Detailed Description

Eosinophilic esophagitis (EoE) is a newly recognized chronic disease that is increasingly being diagnosed in children and adults. Many patients with EoE also have food allergies. EoE is characterized by inflammation and accumulation of a specific type of immune cell, called an eosinophil, in the esophagus. While there have been several large studies of EoE, very few have focused on the roles the immune system, genetics/heredity, and the environment in EoE.

The samples and information collected from participants will help to identify and understand the genetic mechanisms underlying eosinophilic esophagitis.

The Cincinnati Children's Hospital Medical Center will serve as the Central Laboratory for genetic characterization studies.

Study Type

Observational

Enrollment (Actual)

709

Contacts and Locations

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

Study Locations

United States
- Arkansas
  - Little Rock, Arkansas, United States, 72202
    - Arkansas Children's Hospital
- Colorado
  - Denver, Colorado, United States, 80206
    - National Jewish Health
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University
- New York
  - New York, New York, United States, 10029
    - Mount Sinai School of Medicine
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - University of North Carolina

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

6 months to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with biopsy proven Eosinophilic Esophagitis

Description

Inclusion Criteria:

Written informed consent/assent from participant and consent from parent/guardian for minors with agreement for genetic testing;
Documented diagnosis of EoE at any time confirmed by study team (pathology report describing greater than or equal to 15 eosinophils/hpf in peak field of an esophageal biopsy. Participants with eosinophilia in extra-esophageal tissue are permitted).

Exclusion Criteria:

Participants with known infectious causes of esophageal eosinophilia such as esophageal fungus, gastric H. pylori, or systemic parasites;
Participants with a history of persistent eosinophilia greater than 1500 cells/mcl of blood.

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
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis Time Frame: 48 months	A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from >1.5 million genetic markers will be conducted.	48 months

Collaborators and Investigators

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Marc E. Rothenberg, M.D., Ph.D., Children's Hospital Medical Center, Cincinnati
Principal Investigator: Mirna Chehade, MD, MPH, Mt. Sinai School of Medicine

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

Kottyan LC, Davis BP, Sherrill JD, Liu K, Rochman M, Kaufman K, Weirauch MT, Vaughn S, Lazaro S, Rupert AM, Kohram M, Stucke EM, Kemme KA, Magnusen A, He H, Dexheimer P, Chehade M, Wood RA, Pesek RD, Vickery BP, Fleischer DM, Lindbad R, Sampson HA, Mukkada VA, Putnam PE, Abonia JP, Martin LJ, Harley JB, Rothenberg ME. Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease. Nat Genet. 2014 Aug;46(8):895-900. doi: 10.1038/ng.3033. Epub 2014 Jul 13.

Helpful Links

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

April 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria