Overview

This trial has been completed.

Conditions esophagitis, eosinophilic esophagitis
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date April 2011
End date February 2016
Trial size 709 participants
Trial identifier NCT01323803, DAIT CoFAR5

Summary

This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional

Primary Outcomes

Measure
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis
time frame: 48 months

Eligibility Criteria

Male or female participants from 6 months up to 65 years old.

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.

Additional Information

Official title Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)
Principal investigator Marc E. Rothenberg, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).