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

Dysphagia Clinical Trial

Official title:

Predictors of PPI Response in Eosinophilic Esophagitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01479231
• Other study ID #: 11-003759
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: November 22, 2011
• Last updated: April 18, 2012
• Start date: March 2012
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphagia
• Eosinophilic Esophagitis
• Esophagitis
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• dexlansoprazole
Dexlansoprazole 60 mg daily for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hour	Yes
Secondary	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"	30 day	Yes
Secondary	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.	24 hour	Yes
Secondary	Ratio of distal/proximal mean esophageal eosinophil number	Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))	6 weeks	Yes
Secondary	Mean distal eosinophil number	Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )	6 weeks	Yes