Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis (EoE)

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.

Study Overview

• Status: Completed
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Other: Observation Period

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Madison School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Observation Period; 8 week observational period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eosinophil Esophagitis symptom score	8 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sameer Mathur, MD/PhD, UW Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2016
• Primary Completion (Actual): December 13, 2018
• Study Completion (Actual): December 13, 2018

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: EoE
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: 2016-0508; R21AI122103-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes