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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01479231
Recruitment Status : Withdrawn (Souces of funding have been terminated)
First Posted : November 24, 2011
Last Update Posted : April 19, 2012
Information provided by (Responsible Party):
Jeffrey A Alexander, 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.

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

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Study Type : Interventional  (Clinical Trial)
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 : March 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

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

Primary Outcome Measures :
  1. Prevalence of Gastroesophageal Reflux Disease [ Time Frame: 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 :
  1. Heartburn/regurgitation [ Time Frame: 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"

  2. Abnormal 24 hour acid exposure [ Time Frame: 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.

  3. Ratio of distal/proximal mean esophageal eosinophil number [ Time Frame: 6 weeks ]
    Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))

  4. Mean distal eosinophil number [ Time Frame: 6 weeks ]
    Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01479231

Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Jeffrey A Alexander, MD Mayo Clinic
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Responsible Party: Jeffrey A Alexander, MD, Mayo Clinic Identifier: NCT01479231    
Other Study ID Numbers: 11-003759
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012
Keywords provided by Jeffrey A Alexander, Mayo Clinic:
Eosinophilic esophagitis
Proton pump inhibitor
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Deglutition Disorders
Eosinophilic Esophagitis
Esophageal Motility Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action