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

Recruiting now · Phase 3

Conditions studied: HELICOBACTER PYLORI INFECTIONS

In brief

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.

Key facts

Study ID

NCT07576959

Run by

National Taiwan University Hospital

People needed

990

Starts

2026-04-08

Expected to finish

2032-12-31

Last updated by the study team

2026-05-08

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• National Taiwan University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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