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Clinical Trial Summary

Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of proton-pump inhibitor has been reported in previous studies. In patients with concurrent gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of Helicobacter pylori (H. pylori)will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor remains elusive Objective: This study aims to investigate the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication.


Clinical Trial Description

Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of proton-pump inhibitor has been reported in previous studies. In patients with concurrent gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of H. pylori will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor remains elusive Objective: This study aims to investigate the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication Patients and methods: Consecutive reflux patients documented by validated questionnaires (GerdQ) and upper endoscopy will be enrolled from the outpatient clinic. After determination of H. pylori status by urea breath test, those with positive H. pylori infection will be randomized into two groups. Group A (n=100) will be given initial H. pylori eradication with triple therapy for one week, followed by proton-pump inhibitor (PPI) with rabeprazole 20 mg qd for 7 weeks. Group B (n=100) will be given rabeprazole 20 mg qd for 8 weeks and discontinued for 2 weeks. Then, H. pylori eradication with triple therapy will be given for one week, followed by rabeprazole 20 mg qd for 7 weeks. For patients with negative H. pylori infection (n=100), proton-pump inhibitor with rabeprazole 20 mg qd will be given for 8 weeks and discontinued. The incidence and severity of acid-related symptoms will be evaluated with GerdQ at 2 weeks after discontinuation of PPI. The impact of H. pylori infection and H. pylori eradication on the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor will be analyzed. ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01249482
Study type Observational
Source National Taiwan University Hospital
Contact Yi-Chia Lee, MD,PhD
Phone 886-2-23123456
Email yichialee@ntu.edu.tw
Status Recruiting
Phase N/A
Start date September 2010
Completion date August 2012

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