Dysphagia, Eosinophilic Esophagitis, Gastroesophageal Reflux Disease
Conditions
Keywords
GERD, Eosinophilic esophagitis, Proton pump inhibitor, dysphagia
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.
Interventions
DRUGdexlansoprazole
Dexlansoprazole 60 mg daily for 6 weeks
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) ) |
Outcome results
None listed