Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?

Phase 4

Completed

• Conditions: Inflammation; Barrett's Esophagus
• Interventions: Drug: dexlansoprazole; Drug: Omeprazole

• Registration Number: NCT01093755
• Lead Sponsor: Mayo Clinic

Brief Summary

The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of inflammatory mediators (compared to conventional PPIs) in the esophagus, which could potentially lead to decreased recurrence of intestinal metaplasia following endoscopic ablation.

Detailed Description

Patients who achieve complete remission of intestinal metaplasia following ablation will be randomized (using concealed allocation, like the flip of a coin) to either intensive acid suppression with dexlansoprazole 60-90 mg/day or to symptom guided acid suppression with escalating doses of omeprazole (20-60 mg/day) for 6 months. Control of reflux will be assessed using 24 hour ambulatory pH monitoring. The need to escalate drug dosage at the 3 month visit will be determined by presence of excessive acid exposure on ambulatory pH monitoring. Biopsies of esophageal tissue will be obtained at baseline, then at 3 months and 6 months following randomization to measure changes in inflammatory biomarkers.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-02
• Results First Submitted: 2016-02-19
• Results First Submitted QC: 2016-02-19
• Last Update Submitted: 2016-02-19
• Results First Posted: 2016-03-17
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexlansoprazole	dexlansoprazole	Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
omeprazole	Omeprazole	Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.

Primary Outcome Measures

Name	Time	Method
Change in Inflammation Biomarker Tissue PGE2 Level	3 months, 6 months	Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay
Change in Esophageal Inflammation Biomarker COX-2 Gene Expression	3 months, 6 months	Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States