Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication
Recruiting
Phase 3
Interventional Study
HELICOBACTER PYLORI INFECTIONS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 20 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 990 (estimated)
- Sponsor
- National Taiwan University Hospital · Other
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About This Trial
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…
Trial Locations
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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 o…
Contacts