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

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01479231

Collaborator

(none)

Enrollment

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease Eosinophilic Esophagitis Dysphagia	Drug: dexlansoprazole	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Predictors of PPI Response in Eosinophilic Esophagitis

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dexlansoprazole	Drug: dexlansoprazole Dexlansoprazole 60 mg daily for 6 weeks Other Names: Dexilant

Arm

Intervention/Treatment

Experimental: dexlansoprazole

Drug: dexlansoprazole

Dexlansoprazole 60 mg daily for 6 weeks

Other Names:

Dexilant

Outcome Measures

Primary Outcome Measures

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

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) )

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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