Sponge and Eosinophil Peroxidase (EPO) Staining
Primary Purpose
Eosinophilic Esophagitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
swallowed sponge device
Sponsored by
About this trial
This is an interventional diagnostic trial for Eosinophilic Esophagitis focused on measuring EoE
Eligibility Criteria
Inclusion Criteria:
- 18 to 70 years of age
- Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the PPI therapy
- Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk
Exclusion Criteria:
- Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
- Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- Esophageal minimal diameter < 13 mm on structured barium esophagram
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
swallowed sponge device
Arm Description
Swallowing a sponge prior to a clinical upper endoscopy. Patients diagnosed with Eosinophilic Esophagitis (EoE) > than 15 Eosinophils per high power field (phf) and failed to respond to Proton Pump Inhibitors (PPI) therapy. Will be asked to swallow a sponge, this is a 10 minute procedure done in the office prior to their clinical upper endoscopy. This will be sent for histology, >15 Eos phf would be considered active disease. We will compare the results of the sponge using the EPO staining technique compared to histologic response.
Outcomes
Primary Outcome Measures
Sponge pathology verses biopsy results: number of eosinophils
Patients will swallow the sponge prior to a clinical upper endoscopy with biopsies. We will compare upper endoscopy biopsies to the pathology from the cytosponge using the EPO staining technique.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03078023
Brief Title
Sponge and Eosinophil Peroxidase (EPO) Staining
Official Title
Is EPO Staining on Esophageal Sponge Samples a Simple Reliable Method of Accessing Esophageal Eosinophilia?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
July 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Are we able to use the EPO staining technique using the sponge ?
Detailed Description
EPO staining on esophageal sponge samples had a strong association with peak esophageal eosinophil counts on endoscopic biopsy specimens in a small study of 26 patients Using a cut-off of 1.1 absorbance units in a colorimetric assay at a wavelength of 492nm the EPO stain had sensitivity and specificity of 1105 and 83% respectively for a peak eosinophil count of 15 eos/hpf on histologic endoscopic obtained biopsy specimens. The technique of EPO staining is standardized and can be completed in 45 minutes time. Currently, we have found esophageal sponge cytology sensitive and specific for assessment of esophageal eosinophilia. It allows disease activity assessment without endoscopy is much preferred by patients over the standard endoscopic technique of disease assessment. The process of specimen preparation in fairly tedious and interpretation takes significant experience. If EPO staining on non-endoscopic esophageal sponge studies was accurate at assessing disease activity, this is a tool that could be easily performed and interpreted with a rapid turnaround time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
EoE
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
swallowed sponge device
Arm Type
Experimental
Arm Description
Swallowing a sponge prior to a clinical upper endoscopy. Patients diagnosed with Eosinophilic Esophagitis (EoE) > than 15 Eosinophils per high power field (phf) and failed to respond to Proton Pump Inhibitors (PPI) therapy. Will be asked to swallow a sponge, this is a 10 minute procedure done in the office prior to their clinical upper endoscopy. This will be sent for histology, >15 Eos phf would be considered active disease. We will compare the results of the sponge using the EPO staining technique compared to histologic response.
Intervention Type
Device
Intervention Name(s)
swallowed sponge device
Other Intervention Name(s)
brush
Intervention Description
Swallowed sponge: Subjects having a clinical upper endoscopy will be asked to swallow the sponge 2 hours prior to EGD
Primary Outcome Measure Information:
Title
Sponge pathology verses biopsy results: number of eosinophils
Description
Patients will swallow the sponge prior to a clinical upper endoscopy with biopsies. We will compare upper endoscopy biopsies to the pathology from the cytosponge using the EPO staining technique.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 70 years of age
Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the PPI therapy
Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk
Exclusion Criteria:
Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
Esophageal minimal diameter < 13 mm on structured barium esophagram
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthik Ravi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Sponge and Eosinophil Peroxidase (EPO) Staining
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