Mucosal Impedance and Eosinophilic Esophagitis (EoE)

Study Description

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Brief Summary:

Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance?

And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?

Condition or disease	Intervention/treatment	Phase
Eosinophilic Esophagitis	Device: Mucosal Impedance	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
Study Start Date :	September 2013
Estimated Primary Completion Date :	August 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Mucosal Impedance; Patients with Eosinophilic Esophagitis and patient without trouble swallowing,during your clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2.13 mm catheter (tiny tube), called an Intraluminal Impedance, will be passed through the channel of the standard endoscope. This device has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it.; The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) 5 cm above where your stomach and esophagus meet for 5 seconds.; At 10 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds; And at 20 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds.

Device: Mucosal Impedance; Mucosal impedance- a (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) 5 cm above where your stomach and esophagus meet for 5 seconds.; At 10 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds; And at 20 cm above where your stomach and esophagus meet the catheter will be placed for 5 seconds. This will determine if people with eosinophilic esophagitis (EoE) have an increased esophageal mucosa impedance (food getting into the esophageal tissue).; Other Names: ph impedance; ph monitor

Outcome Measures

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Primary Outcome Measures :

1. Effective treatment is defined by the elimination of esophageal eosinophilia on follow up endoscopic biopsy. [ Time Frame: basesline to one year ]
   As a pilot, ten patients will be studied before and after treatment for eosinophilic esophagitis. This number of patients will be increased if there are treatment failures until there is a total of ten effectively treated patients studied. Effective treatment is defined by the elimination of esophageal eosinophilia on follow up endoscopic biopsy. Ten control patients without esophageal disease will be studied.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

• Adults ages 18-90 undergoing clinically indicated upper endoscopy
• Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
• Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD with normal appearing esophageal mucosa.

Exclusion criteria:

• Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
• Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
• Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Contacts and Locations

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Locations

United States, Minnesota
Mayo Clinic in Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M. Geno, CCRP 507-538-0367 geno.debra@mayo.edu
Contact: Lori A. Kryzer 507-538-2403` kryzer.lori@mayo.edu

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:	David Katzka, MD	Mayo Clinic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	David A. Katzka, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01953575 History of Changes
Other Study ID Numbers:	13-005778
First Posted:	October 1, 2013
Last Update Posted:	October 11, 2017
Last Verified:	October 2017

Keywords provided by David A. Katzka, Mayo Clinic:

Mucosal Impedance; Eosinophilic Esophagitis; EoE

Additional relevant MeSH terms:

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