Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02934152
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2016-10-06
Brief Title:
Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n100 will be given early H pylori eradication with triple therapy for two weeks group B n100 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 n200 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None