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

NCT07576959 | Recruiting Phase 3

• 1 other identifier: 202602016MINC
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Per-protocol (PP) eradication rate; adverse event profiles

  6-8 weeks

Study Arms (2)

Bismuth Add-on to Vonoprazan Dual Therapy

EXPERIMENTAL

14-day bismuth-vonoprazan-amoxicillin triple therapy

Drug: Bismuth Add-on to Vonoprazan Dual Therapy

Vonoprazan Dual Therapy

ACTIVE COMPARATOR

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

Drug: Vonoprazan dual therapy

Interventions

Bismuth Add-on to Vonoprazan Dual Therapy DRUG

bismuth, vonoprazan and amoxicillin for 14 days

Bismuth Add-on to Vonoprazan Dual Therapy

Vonoprazan dual therapy DRUG

vonoprazan and amoxicillin for 14 days

Vonoprazan Dual Therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Central Study Contacts

Mei-Jyh Chen, MD, PhD

CONTACT

886-2-23123456 Ext. 265427; migichen@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 8, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

TW (1)