Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: RAK therapy; Drug: RBAK therapy

• Registration Number: NCT03108287
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori (H. pylori). A total of 162 patients with H. pylori infection were randomly assigned to either the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81). The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen.

Detailed Description

Once confirmed with H. pylori infection and having signed the informed consent, participants were randomly assigned to either the standard triple-therapy group (RAK: rabeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days) or the bismuth plus standard triple-therapy group (RBAK: rabeprazole 20 mg, bismuth subcitrate 360 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days). A computer-generated random number was chosen for randomization. The patients and physicians were not blinded to the therapy assigned.

After completion of H. pylori eradication therapy, participants were asked to come back for collection of the information on any adverse event of drug compliance. In order to avoid false negative results, they were also asked to have a 4-week proton pump inhibitor, antibiotic and bismuth washout period before further examination of H. pylori status. The second endoscopy with rapid urea test, histology and culture or 13 C-urea breath test (UBT) for those who refused endoscopic exams was carried out at the end of the washout period. Those who did not return to confirm their H. pylori status were deemed as treatment failure in intention-to-treat (ITT) analysis.

Study Timeline

• Study Start: 2013-04-01
• Primary Completion: 2015-01-31
• Study Completion: 2015-02-28
• Status Verified: 2017-03
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

1. male or non-pregnant female aged more than 20 y/r
2. H.pylori-infected
3. mental and legal ability to give a written informed consent

Exclusion Criteria

1. allergy to any drug in the study
2. prior gastric surgery, severe concomitant diseases (e.g., decompensate liver cirrhosis, uremia, gastric cancer)
3. previous H. pylori eradication therapy
4. pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAK therapy	RAK therapy	rabeprazole+amoxicillin+clarithromycin
RBAK therapy	RBAK therapy	rabeprazole+amoxicillin+clarithromycin+bismuth subcitrate

Primary Outcome Measures

Name	Time	Method
The rate of H.pylori eradication	4 weeks after finishing study drugs	Helicobacter pylori eradication was assessed by ¹³C-urea breath test. \[cutoff value(\<4‰)\]

Secondary Outcome Measures

Name	Time	Method
rate of drug compliance	4 weeks after finishing study drugs	good drug compliance measure by no of subjects taking \>80% medicines
rate of side effects	4 weeks after finishing study drugs	Score side effects were mild, moderate or severe according to their influence on daily activities