NCT02934152

Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 H. pylori will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor (PPI) 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 Expected result: The investigators will find out the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication

Detailed 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 (UBT), those with positive H. pylori infection will be randomized into two groups. Group A (n=100) will be given early H. pylori eradication with triple therapy for two weeks; group B (n=100) will be given rabeprazole 20 mg qd for 4 weeks, followed by H. pylori eradication with triple therapy for two weeks. The investigators will then determine the H. pylori status by urea breath test and the incidence and severity of acid-related symptoms with GerdQ at 4 weeks after H. pylori eradication. For patients with negative H. pylori infection (n=200), proton-pump inhibitor with rabeprazole 20 mg qd will be given for 8 weeks and the incidence and severity of acid-related symptoms will be evaluated with GerdQ at 4 weeks after discontinuation of PPI. The impact of H. pylori infection and H. pylori eradication and its timing on the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor will be analyzed. Expected result: The investigators will find out the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	H pylori eradication	H pylori eradication
OTHER	H pylori eradication timing	Early or late eradication

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-10-14
• Last updated: 2016-10-19

Locations

1 site across 1 country: Taiwan