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

Mayo Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Gastroesophageal Reflux Disease Eosinophilic Esophagitis Dysphagia

Interventions

dexlansoprazoleDRUG

Dexlansoprazole 60 mg daily for 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 2"yes", 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

Outcomes

Primary Outcomes

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.

Time frame: 24 hour

Secondary Outcomes

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"

Time frame: 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.

Time frame: 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))

Time frame: 6 weeks

Mean distal eosinophil number

Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )

Time frame: 6 weeks

Data from ClinicalTrials.gov

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