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

Phase 1

Withdrawn

• Conditions: Gastroesophageal Reflux Disease; Eosinophilic Esophagitis; Dysphagia
• Interventions: Drug: dexlansoprazole

• Registration Number: NCT01479231
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-23
• Study First Posted: 2011-11-24
• Study Start: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dexlansoprazole	dexlansoprazole	-

Primary Outcome Measures

Name	Time	Method
Prevalence of Gastroesophageal Reflux Disease	24 hour	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.

Secondary Outcome Measures

Name	Time	Method
Heartburn/regurgitation	30 day	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"
Abnormal 24 hour acid exposure	24 hour	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.
Ratio of distal/proximal mean esophageal eosinophil number	6 weeks	Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))
Mean distal eosinophil number	6 weeks	Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )