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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
H pylori eradication
H pylori eradication timing
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal reflux disease, Helicobacter pylori

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) validated by standard questionnaire GerdQ.16
  2. Aged >= 20 years old.
  3. Willing to receive H. pylori eradication therapy.

Exclusion criteria:

  1. Symptomatic reflux patients with high grade erosive esophagitis (LA classification Grade C and D) or Barrett's esophagus documented by endoscopy.
  2. Symptomatic reflux patients with a history of using PPI in recent one month.
  3. Subjects with known allergy to PPI.
  4. Peptic ulcer disease
  5. Cancers of the esophagus, stomach, and duodenum
  6. Esophageal or gastric varices
  7. Active upper gastrointestinal bleeding within 7 days prior to enrollment
  8. Status after total or subtotal gastrectomy
  9. Pregnancy
  10. Use of anticoagulants or antiplatelets within one week prior to enrollment
  11. Subjects with bleeding tendency

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Early eradication

Late eradication

Negative Hp

Arm Description

Group A (H pylori eradication timing: early eradication, n=100): Initial H pylori eradication with triple therapy (rabeprazole 20 mg qd, amoxicillin 1gm bid, clarithromycin 500 mg bid) for two weeks.

Group B (H pylori eradication timing: late eradication, n=100): PPI with rabeprazole 20 mg qd for 4 weeks, followed by H pylori eradication with triple therapy for two weeks

For patients with negative H. p infection documented by UBT (Group C, n=200), No H pylori eradication treatment will be given but PPI with rabeprazole 20 mg qd will be given for 8 weeks.

Outcomes

Primary Outcome Measures

Acid rebound
Development of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication

Secondary Outcome Measures

Severity of acid rebound
Severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication. The severity will be determined by the change of the scores of total and respective symptom items of the symptom questionnaire GerdQ.

Full Information

First Posted
October 6, 2016
Last Updated
October 17, 2016
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02934152
Brief Title
Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication
Official Title
Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 (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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Gastroesophageal reflux disease, Helicobacter pylori

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early eradication
Arm Type
Experimental
Arm Description
Group A (H pylori eradication timing: early eradication, n=100): Initial H pylori eradication with triple therapy (rabeprazole 20 mg qd, amoxicillin 1gm bid, clarithromycin 500 mg bid) for two weeks.
Arm Title
Late eradication
Arm Type
Experimental
Arm Description
Group B (H pylori eradication timing: late eradication, n=100): PPI with rabeprazole 20 mg qd for 4 weeks, followed by H pylori eradication with triple therapy for two weeks
Arm Title
Negative Hp
Arm Type
Active Comparator
Arm Description
For patients with negative H. p infection documented by UBT (Group C, n=200), No H pylori eradication treatment will be given but PPI with rabeprazole 20 mg qd will be given for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
H pylori eradication
Other Intervention Name(s)
rabeprazole, amoxicillin, clarithromycin
Intervention Description
H pylori eradication
Intervention Type
Other
Intervention Name(s)
H pylori eradication timing
Intervention Description
Early or late eradication
Primary Outcome Measure Information:
Title
Acid rebound
Description
Development of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Severity of acid rebound
Description
Severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication. The severity will be determined by the change of the scores of total and respective symptom items of the symptom questionnaire GerdQ.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with typical reflux symptoms (heartburn and/or acid regurgitation) validated by standard questionnaire GerdQ.16 Aged >= 20 years old. Willing to receive H. pylori eradication therapy. Exclusion criteria: Symptomatic reflux patients with high grade erosive esophagitis (LA classification Grade C and D) or Barrett's esophagus documented by endoscopy. Symptomatic reflux patients with a history of using PPI in recent one month. Subjects with known allergy to PPI. Peptic ulcer disease Cancers of the esophagus, stomach, and duodenum Esophageal or gastric varices Active upper gastrointestinal bleeding within 7 days prior to enrollment Status after total or subtotal gastrectomy Pregnancy Use of anticoagulants or antiplatelets within one week prior to enrollment Subjects with bleeding tendency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping-Huei Tseng, MDPHD
Phone
886-972652009
Email
pinghuei@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Hsi Hsu
Phone
886-2-23123456
Ext
63863
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Huei Tseng, MDPHD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping-Huei Tseng, MDPHD
Phone
886-972652009
Email
pinghuei@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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