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

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

Study Overview

• Status: Unknown
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: H pylori eradication; Other: H pylori eradication timing

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

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ping-Huei Tseng, MDPHD; Phone Number: 886-972652009; Email: pinghuei@ntu.edu.tw
• Study Contact Backup: Name: Yen-Hsi Hsu; Phone Number: 63863 886-2-23123456

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
    • Contact: Ping-Huei Tseng, MDPHD; Phone Number: 886-972652009; Email: pinghuei@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early eradication; 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.	Drug: H pylori eradication; H pylori eradication; Other Names: rabeprazole, amoxicillin, clarithromycin; Other: H pylori eradication timing; Early or late eradication
Experimental: Late eradication; 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	Drug: H pylori eradication; H pylori eradication; Other Names: rabeprazole, amoxicillin, clarithromycin; Other: H pylori eradication timing; Early or late eradication
Active Comparator: Negative Hp; 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.	Drug: H pylori eradication; H pylori eradication; Other Names: rabeprazole, amoxicillin, clarithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acid rebound	Development of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ping-Huei Tseng, MDPHD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Gastroesophageal reflux disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole; Amoxicillin; Clarithromycin
• Other Study ID Numbers: 201607055MINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No