Clinical Trials Directory

Trials / Completed

CompletedNCT02775045

Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis

Status
Completed
Phase
Study type
Observational
Enrollment
28 (actual)
Sponsor
University of Wisconsin, Madison · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to improve the overall management of patients with Eosinophil Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the endoscopy procedure. The investigators plan to identify a biomarker in the blood (a measurable substance) that tracks with disease activity and will reduce the need for follow-up endoscopies.

Detailed description

By definition, Eosinophil Esophagitis involves the presence of eosinophils in the esophageal mucosa. Although incompletely understood, the pathophysiology of Eosinophil Esophagitis is thought to include food allergen driven inflammation in the esophageal mucosa that triggers release of mediators for recruitment of eosinophils. The mediators, such as eotaxin, invoke eosinophil activation and trafficking into the esophageal tissue. The subsequent release of mediators from eosinophils and other cells, including mast cells and basophils, promotes inflammation and fibrosis resulting in Eosinophil Esophagitis symptoms. This protocol focuses on early eosinophil activation events in Eosinophil Esophagitis in the peripheral circulation, specifically activation of surface β1 integrin, as a biomarker for disease activity reflecting eosinophils destined for trafficking into the esophagus. Demonstrating a correlation between disease activity and a peripheral biomarker may ultimately facilitate a timelier, less invasive and less costly management strategy for Eosinophil Esophagitis.

Conditions

Interventions

TypeNameDescription
OTHERObservation Period8 week observational period

Timeline

Start date
2016-08-30
Primary completion
2018-12-13
Completion
2018-12-13
First posted
2016-05-17
Last updated
2019-01-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02775045. Inclusion in this directory is not an endorsement.