Actively Recruiting
Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial
Led by National Taiwan University Hospital · Updated on 2026-05-08
990
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two treatment approaches for first-time Helicobacter pylori infection. The study compares a 14-day triple therapy that includes bismuth, vonoprazan, and amoxicillin with a 14-day dual therapy of vonoprazan and amoxicillin without bismuth. The trial also examines how these treatments affect gut bacteria, antibiotic resistance development, and changes in metabolic syndrome markers before and after treatment. Participants will be randomly assigned to one of two groups: one receiving the bismuth-supplemented triple therapy and the other receiving the dual therapy without bismuth. Both treatments last for 14 days. This is an open-label, randomized controlled trial designed to assess whether adding bismuth enhances treatment effectiveness or is at least not worse than the dual therapy alone. During the study, participants will be monitored for eradication of H. pylori infection using intention-to-treat analysis at 6 to 8 weeks after treatment. Secondary assessments include per-protocol eradication rates and monitoring for any adverse events. The study involves treatment adherence, safety monitoring, and evaluation of gut microbiota changes over the course of the trial. Participants will be involved from the start of treatment through follow-up assessments.
CONDITIONS
Brief Title
Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy.
- Individuals willing to receive first-line eradication therapy.
- Study participants must be 20 years of age or older.
You will not qualify if you...
- Individuals with a history of gastrectomy (stomach removal surgery).
- Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug).
- Pregnant or breastfeeding women.
- Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors.
- Patients with chronic hepatitis (AST [Aspartate Aminotransferase] or ALT [Alanine Aminotransferase] > 100 U/L).
- Individuals unwilling to comply with the treatment plan or sign the informed consent form.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive either a 14-day bismuth-vonoprazan-amoxicillin triple therapy or a 14-day vonoprazan-amoxicillin dual therapy to eradicate Helicobacter pylori infection.
Daily medication with follow-up visits as scheduled by the study team
Duration - 6 to 8 weeks
Participants are monitored for eradication success and safety assessment approximately 6 to 8 weeks after treatment.
1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
M
Mei-Jyh Chen, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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