Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis

Study Overview
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Brief Summary
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The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia.

Official Title
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Predictors of PPI Response in Eosinophilic Esophagitis

Conditions
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Gastroesophageal Reflux Disease, Eosinophilic Esophagitis, Dysphagia

Intervention / Treatment
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* Drug: dexlansoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age < 80 years of age 14 eosinophils / hpf on biopsies from esophagus Abnormal validated Mayo dysphagia questionnaire (MDQ-30) (question 2yes, question 4 > moderate and question 7 > once a week) Clinically performed EGD with > 14 eosinophils/hpf completed within last 3 months Exclusion Criteria: Other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm) Dilatation of esophagus at time of index endoscopy Treatment with topical steroid within 3 months of index endoscopy Treatment with PPI in last 30 days prior to index EGD Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexlansoprazole<br> | Drug: dexlansoprazole<br>* Dexlansoprazole 60 mg daily for 6 weeks<br>* Other names: Dexilant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Gastroesophageal Reflux Disease | Prevalence of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis (EoE) Description: The definition of GERD is acid exposure time of >4.2% over 24 hour period, as measured by pH monitoring. | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heartburn/regurgitation | Heartburn/regurgitation (as measured by:) Mayo Dysphagia Questionnaire - 30 Day Validated 28 item instrument; 0 = no dysphagia, higher levels indicate greater dysphagia severity. Dysphagia. 2010 Sep;25(3):221-30 Measured by units on a scale | 30 day | 
| Abnormal 24 hour acid exposure | Abnormal 24 hour acid exposure (as measured by pH monitoring) Description: A thin plastic catheter is passed through one nostril, down the back of the throat, and into the esophagus as the patient swallows. The tip of the catheter contains a sensor that senses acid. The catheter protruding from the nose is connected to a recorder that registers each reflux of acid. The catheter is in place for 24 hours, when is removed and the recorder is attached to a computer so that the data can be downloaded. | 24 hour | 
| Ratio of distal/proximal mean esophageal eosinophil number | Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD)) | 6 weeks | 
| Mean distal eosinophil number | Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) ) | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Eosinophilic esophagitis, Proton pump inhibitor, dysphagia