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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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Eosinophilic Esophagitis focused on measuring EoE

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 8, 2017
Last Updated
April 14, 2022
Sponsor
Mayo Clinic
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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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