Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication

Helicobacter Pylori Eradication Clinical Trial

Official title:

Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06349486
• Other study ID #: KMUHIRB-F(II)-20230179
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Kaohsiung Medical University
• Contact: Deng-Chyang Wu, MD, PHD
• Phone: 88673121101
• Email: dechwu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.

2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.

Description:

For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.

Exclusion Criteria:

1. Those who have ever received Helicobacter pylori sterilization treatment.

2. Those who are allergic to the drugs used in this research.

3. Those who have had stomach surgery.

4. Those with severe liver cirrhosis or uremia or malignant tumors.

5. Women who are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication

Intervention

Drug:
• vonoprazan, amoxicillin, tripotassium dicitrate bismuthate
bismuth-amoxicillin-vonoprazan triple therapy
• vonoprazan, amoxicillin
vonoprazan-amoxicillin dual therapy
• rabeprazole, amoxicillin, clarithromycin
proton pump inhibitor-based standard triple therapy

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the eradication rate of Helicobacter pylori	evalute eradication outcome by 13C urea breath test	8 week after finishing study drugs
Secondary	genotype analysis	CYP3A4, CYP2C19 and IL-1B -511 genotypes	1 day