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Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis
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.
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|Eligible Ages||18 Years and Over|
- - Male or female with no health concerns that might affect the outcome of the study, - Age 18 years of age and older - Esophageal dysfunction with a predominant symptom of solid food dysphagia and/or esophageal food impaction - Esophageal eosinophilia (>15 eosinophils/HPF) shown on biopsy - In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.
- - Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma.
- - Pregnant or lactating females or has a planned pregnancy during the course of the study.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Wisconsin, Madison|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Sameer Mathur, MD/PhD|
|Principal Investigator Affiliation||UW Madison|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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