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| ID | Type | Description | Link |
|---|---|---|---|
| R21AI122103-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eosinophil esophagitis | Adult patients (>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 eosinophil/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation Period | Other | 8 week observational period |
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| Measure | Description | Time Frame |
|---|---|---|
| Eosinophil Esophagitis symptom score | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 EOS/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy.
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| Name | Affiliation | Role |
|---|---|---|
| Sameer Mathur, MD/PhD | UW Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Madison School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33891621 | Derived | Bartig KA, Lee KE, Mosher DF, Mathur SK, Johansson MW. Platelet association with leukocytes in active eosinophilic esophagitis. PLoS One. 2021 Apr 23;16(4):e0250521. doi: 10.1371/journal.pone.0250521. eCollection 2021. |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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55 mL of blood will be drawn during V1 and V2. The blood will be drawn to save serum, for flow cytometry to answer the research questions, to isolate plasma and purify eosinophils for banking of whole cell protein and RNA, and to allow for genetic analysis of DNA. DNA will be isolated for directed genetic analysis of genes related to eosinophil biology and inflammation associated with EoE. Currently, these include ORMDL3, eotaxin-3, and IL-13 and may include others upon identification in the literature. This limited analysis is not expected to be sufficient for subject identification nor is it expected that the genes will be predictive of any other disease process. The genetic portion of the blood draw will not be optional.
| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |