Adding bismuth to vonoprazan‑amoxicillin therapy for H. pylori

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label randomized controlled trial will enroll about 990 treatment-naïve adults with confirmed H. pylori infection and randomize them to 14 days of vonoprazan‑amoxicillin with bismuth or vonoprazan‑amoxicillin alone. The primary comparison is eradication rate, with safety monitoring and secondary analyses of gut microbiota changes, antibiotic resistance development, and metabolic syndrome markers before and after treatment. The trial is conducted at National Taiwan University Hospital and excludes patients with prior eradication therapy, significant liver or renal disease, pregnancy or breastfeeding, or prior gastrectomy. Results will be analyzed by intention-to-treat and per-protocol approaches to determine superiority or non-inferiority.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Mei-Jyh Chen, MD, PhD
• Email: migichen@ntuh.gov.tw
• Phone: 886-2-23123456 Ext. 265427

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.