Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication

Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial

This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based dual therapy ( triple therapy) versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication. Furthermore, the investigators will investigate the impact of these eradication regimens on the gut microbiota, the development of antibiotic resistance, and changes in metabolic syndrome indicators pre- and post-treatment.

Study Overview

• Status: Recruiting
• Conditions: HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: Drug: Bismuth Add-on to Vonoprazan Dual Therapy; Drug: Vonoprazan dual therapy

Detailed Description

Background: Although bismuth is not an antibiotic, it enhances antibiotic efficacy through multiple synergistic mechanisms. Currently, it remains unknown whether adding bismuth to a 14-day bismuth-vonoprazan-amoxicillin triple therapy is superior or non-inferior to the vonoprazan-amoxicillin dual therapy alone.

Objectives: This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based triple therapy versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication.

Hypothesis: The investigators hypothesize that the efficacy of a 14-day bismuth-vonoprazan triple therapy is superior or non-inferior to that of a 14-day vonoprazan-based dual therapy without bismuth.

Methods:

Study Design: An open-label, randomized controlled trial (RCT). Participants: The investigators intend to recruit 990 treatment-naïve patients with confirmed H. pylori infection.

Intervention and Randomization: Eligible participants will be randomized into one of two groups:

• Group A: 14-day bismuth-vonoprazan triple therapy.
• Group B: 14-day vonoprazan-based dual therapy (without bismuth).

• Study Type: Interventional
• Enrollment (Estimated): 990
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mei-Jyh Chen, MD, PhD; Phone Number: 886-2-23123456 Ext. 265427; Email: migichen@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Mei-Jyh Chen, MD; Phone Number: 886-2-23123456 Ext. 63541; Email: migichen@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy.
2. Individuals willing to receive first-line eradication therapy.
3. Study participants must be 20 years of age or older.

Exclusion Criteria:

1. Individuals with a history of gastrectomy (stomach removal surgery).
2. Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug).
3. Pregnant or breastfeeding women.
4. Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors.
5. Patients with chronic hepatitis (AST [Aspartate Aminotransferase] or ALT [Alanine Aminotransferase] > 100 U/L).
6. Individuals unwilling to comply with the treatment plan or sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bismuth Add-on to Vonoprazan Dual Therapy; 14-day bismuth-vonoprazan-amoxicillin triple therapy	Drug: Bismuth Add-on to Vonoprazan Dual Therapy; bismuth, vonoprazan and amoxicillin for 14 days
Active Comparator: Vonoprazan Dual Therapy; 14-day vonoprazan-based dual therapy (without bismuth).	Drug: Vonoprazan dual therapy; vonoprazan and amoxicillin for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate determined by Intention-to-Treat (ITT) analysis	Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment.	6-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per-protocol (PP) eradication rate; adverse event profiles	Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment. A standard interview and questionaire will be used toassess the adverse effects.	6-8 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 202602016MINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No