Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
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.
Gastroesophageal Reflux Disease
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Predictors of PPI Response in Eosinophilic Esophagitis|
- Prevalence of Gastroesophageal Reflux Disease [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]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.
- Heartburn/regurgitation [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]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 [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))
- Mean distal eosinophil number [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )
|Study Start Date:||March 2012|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Dexlansoprazole 60 mg daily for 6 weeks
Other Name: Dexilant
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479231
|Principal Investigator:||Jeffrey A Alexander, MD||Mayo Clinic|