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

National Taiwan University

Status and phase: Enrolling; Phase 3

Conditions: HELICOBACTER PYLORI INFECTIONS

Treatments: Drug: Vonoprazan dual therapy; Drug: Bismuth Add-on to Vonoprazan Dual Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07576959

202602016MINC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 990 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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990 participants in 2 patient groups

Bismuth Add-on to Vonoprazan Dual Therapy

Experimental group

Description:

14-day bismuth-vonoprazan-amoxicillin triple therapy

Treatment:

Drug: Bismuth Add-on to Vonoprazan Dual Therapy

Vonoprazan Dual Therapy

Active Comparator group

Description:

14-day vonoprazan-based dual therapy (without bismuth).

Treatment:

Drug: Vonoprazan dual therapy