Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Mei-Jyh Chen, MD, PhD
migichen@ntuh.gov.tw
886-2-23123456 Ext. 265427
Time Frame
Start Date: 2026-04-08
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 990
Treatments
Experimental: Bismuth Add-on to Vonoprazan Dual Therapy
14-day bismuth-vonoprazan-amoxicillin triple therapy
Active_comparator: Vonoprazan Dual Therapy
14-day vonoprazan-based dual therapy (without bismuth).
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital