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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02934152
• Other study ID #: 201607055MINC
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 6, 2016
• Last updated: October 17, 2016
• Start date: October 2016
• Est. completion date: September 2019

Study information

• Verified date: October 2016
• Source: National Taiwan University Hospital
• Contact: Ping-Huei Tseng, MDPHD
• Phone: 886-972652009
• Email: pinghuei[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

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 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• H pylori eradication
H pylori eradication

Other:
• H pylori eradication timing
Early or late eradication

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acid rebound	Development of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication	4 weeks	No
Secondary	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	No