Sponge and Eosinophil Peroxidase (EPO) Staining

NCT03078023 | Completed DMC

• 1 other identifier: 16-009403
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Are we able to use the EPO staining technique using the sponge ?

Conditions

Eosinophilic Esophagitis

Keywords

EoE

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

swallowed sponge device

EXPERIMENTAL

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.

Device: swallowed sponge device

Interventions

swallowed sponge device DEVICE

Swallowed sponge: Subjects having a clinical upper endoscopy will be asked to swallow the sponge 2 hours prior to EGD

Also known as: brush

swallowed sponge device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Officials

• Karthik Ravi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 13, 2017
• Study Start: March 8, 2017
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)