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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108287
• Other study ID #: KMUH-IRB-20120028
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2017
• Last updated: April 20, 2017
• Start date: April 1, 2013
• Est. completion date: February 28, 2015

Study information

• Verified date: March 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: February 28, 2015
• Est. primary completion date: January 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• RAK therapy
rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg twice-daily
• RBAK therapy
rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg, bismuth subcitrate 360mg twice-daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of H.pylori eradication	Helicobacter pylori eradication was assessed by ¹³C-urea breath test. [cutoff value(<4‰)]	4 weeks after finishing study drugs
Secondary	rate of drug compliance	good drug compliance measure by no of subjects taking >80% medicines	4 weeks after finishing study drugs
Secondary	rate of side effects	Score side effects were mild, moderate or severe according to their influence on daily activities	4 weeks after finishing study drugs