Mucosal Impedance and Eosinophilic Esophagitis

Study Overview
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Brief Summary
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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?

Official Title
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Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Device: Mucosal Impedance
* Procedure: Upper Endoscopy


Participation Criteria
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Eligibility Criteria
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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 Gastroesophageal reflux disease (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Eosinophilic Esophagitis<br>Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy | Device: Mucosal Impedance<br>* A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.<br>* Other names: ph monitor;Procedure: Upper Endoscopy<br>* Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum.<br>* Other names: Esophagogastroduodenoscopy (EGD);|
| Experimental: Inactive Eosinophilic Esophagitis<br>Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy | Device: Mucosal Impedance<br>* A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.<br>* Other names: ph monitor;Procedure: Upper Endoscopy<br>* Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum.<br>* Other names: Esophagogastroduodenoscopy (EGD);|
| Placebo Comparator: Control group<br>Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy | Procedure: Upper Endoscopy<br>* Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum.<br>* Other names: Esophagogastroduodenoscopy (EGD);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal Mucosal Impedance (MI) | An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction. | baseline to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucosal Impedance, Eosinophilic Esophagitis, EoE