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

This study has been withdrawn prior to enrollment.
(Souces of funding have been terminated)
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic Identifier:
First received: November 22, 2011
Last updated: April 18, 2012
Last verified: April 2012
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 Intervention Phase
Gastroesophageal Reflux Disease
Eosinophilic Esophagitis
Drug: dexlansoprazole
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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) )

Enrollment: 0
Study Start Date: March 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexlansoprazole Drug: dexlansoprazole
Dexlansoprazole 60 mg daily for 6 weeks
Other Name: Dexilant


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01479231

Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Jeffrey A Alexander, MD Mayo Clinic
  More Information

Responsible Party: Jeffrey A Alexander, MD, Mayo Clinic Identifier: NCT01479231     History of Changes
Other Study ID Numbers: 11-003759 
Study First Received: November 22, 2011
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Eosinophilic esophagitis
Proton pump inhibitor

Additional relevant MeSH terms:
Eosinophilic Esophagitis
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Leukocyte Disorders
Proton Pump Inhibitors
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2016