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

NCT ID: NCT02934152

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-09-30

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

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

H pylori eradication

Intervention Type: DRUG

H pylori eradication

H pylori eradication timing

Intervention Type: OTHER

Early or late eradication

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

Group Type: EXPERIMENTAL

H pylori eradication

Intervention Type: DRUG

H pylori eradication

H pylori eradication timing

Intervention Type: OTHER

Early or late eradication

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.

Group Type: ACTIVE_COMPARATOR

H pylori eradication

Intervention Type: DRUG

H pylori eradication

Interventions

H pylori eradication

H pylori eradication

Intervention Type: DRUG

H pylori eradication timing

Early or late eradication

Intervention Type: OTHER

Other Intervention Names

rabeprazole, amoxicillin, clarithromycin

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping-Huei Tseng, MDPHD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

Central Contacts

Ping-Huei Tseng, MDPHD

Role: CONTACT

pinghuei@ntu.edu.tw

886-972652009

Yen-Hsi Hsu

Role: CONTACT

886-2-23123456 ext. 63863

Facility Contacts

Ping-Huei Tseng, MDPHD

Role: primary

pinghuei@ntu.edu.tw

886-972652009

References

Hu KY, Tseng PH, Liou JM, Tu CH, Chen CC, Lee YC, Chiu HM, Wu MS. Rebound of Reflux-Related Symptoms After Helicobacter pylori Eradication in Patients With Gastroesophageal Reflux Disease: A Prospective Randomized Study. Helicobacter. 2025 Jan-Feb;30(1):e70023. doi: 10.1111/hel.70023.

Reference Type: DERIVED

PMID: 40007457 (View on PubMed)

Other Identifiers

201607055MINC

Identifier Type: -

Identifier Source: org_study_id