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

Mayo Clinic

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Dysphagia; Eosinophilic Esophagitis; Gastroesophageal Reflux Disease

Treatments: Drug: dexlansoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01479231

11-003759

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

dexlansoprazole

Experimental group

Treatment:

Drug: dexlansoprazole