NCT07576959 Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication
| NCT ID | NCT07576959 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | National Taiwan University Hospital |
| Condition | HELICOBACTER PYLORI INFECTIONS |
| Study Type | INTERVENTIONAL |
| Enrollment | 990 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 990 participants in total. It began in 2026-04-08 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07576959 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying HELICOBACTER PYLORI INFECTIONS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07576959 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 990 participants.
Is NCT07576959 currently recruiting?
Yes, NCT07576959 is actively recruiting participants. Contact the research team at migichen@ntuh.gov.tw for enrollment information.
Where is the NCT07576959 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07576959 clinical trial?
NCT07576959 is sponsored by National Taiwan University Hospital. The trial plans to enroll 990 participants.