Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2019 |
| Start Date: | August 30, 2016 |
| End Date: | December 13, 2018 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Major health problems such as autoimmune disease, heart disease, type I and II
diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed
health problems are definitive exclusion but decisions regarding major health problems
not listed will be based upon the judgment of the investigator,
- Pregnant or lactating females or has a planned pregnancy during the course of the
study.
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