RecruitingPhase 3

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

Taiwan990 participantsStarted 2026-04-08

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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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.

What they're measuring

Eradication rate determined by Intention-to-Treat (ITT) analysis

Timeframe: 6-8 weeks

Trial details

NCT IDNCT07576959

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Mei-Jyh Chen, MD, PhD

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

View on ClinicalTrials.gov More HELICOBACTER PYLORI INFECTIONS trials