Effect of Bismuth Add-on to Dual Therapy for Helicobacter... | NCT07576959

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

NCT07576959

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

May 8, 2026Actual

Enrollment

990Estimated

Phase

Phase 3

Conditions

HELICOBACTER PYLORI INFECTIONS

Interventions

Bismuth Add-on to Vonoprazan Dual Therapy
Vonoprazan dual therapy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2026Estimated

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Apr 27, 2026

First Submission Date that Met QC Criteria

May 4, 2026

First Posted Date

May 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

990Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bismuth Add-on to Vonoprazan Dual Therapy	Drug	bismuth, vonoprazan and amoxicillin for 14 days	Bismuth Add-on to Vonoprazan Dual Therapy

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mei-Jyh Chen, MD, PhD	Contact	886-2-23123456 Ext. 265427		migichen@ntuh.gov.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan