Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection
Official title: Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy in the First-line Anti-Helicobacter Pylori Treatment
Run by Kaohsiung Medical University · NCT07358130 · Data updated 2026-11-12
This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 552 (estimated) |
| Sponsor | Kaohsiung Medical University Academic / other |
| Locations | 1 site (Kaohsiung City) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | November 15, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT07358130 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed H. pylori infection who are not pregnant or breastfeeding, have no prior gastric surgery, no severe liver cirrhosis or uremia, no recent malignancy, and are not taking contraindicated drugs such as atazanavir or rilpivirine are eligible.
✕Probably not a fit
Patients with known hypersensitivity to the study drugs, prior gastric surgery, severe liver cirrhosis or uremia, recent malignancy, pregnancy or breastfeeding, or current use of atazanavir or rilpivirine are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, open-label trial enrolling 552 adults with H. pylori infection at hospitals in Taiwan. Participants are randomized 1:1 to receive either 14 days of bismuth-amoxicillin-vonoprazan triple therapy or 14 days of bismuth-rabeprazole-tetracycline-metronidazole quadruple therapy. Follow-up at week 2 checks adherence and side effects, and H. pylori status is evaluated at week 6 using the C13-urea breath test. The study will compare eradication and adverse event rates and analyze how bacterial antibiotic resistance and patient genotypes (CYP3A4, CYP2C19, IL-1B -511) affect outcomes.
Why it matters
Potential benefit: If successful, the regimen could raise eradication rates and offer a simpler or better-tolerated first-line option for adults with H. pylori.
How similar studies have gone: Previous studies of vonoprazan-based regimens have shown higher eradication rates than some proton-pump inhibitor regimens, and bismuth quadruple therapy is an established standard, but the specific bismuth-amoxicillin-vonoprazan combination is less extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with Helicobacter pylori infection Exclusion Criteria: 1. Subjects with known hypersensitivity to the study drug. 2. Subjects with a history of gastric surgery. 3. Subjects with severe liver cirrhosis or uremia. 4. Subjects with a history of malignancy within the past five years. 5. Pregnant or breastfeeding women. 6. Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.
Where it's running
-
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan Recruiting
Study contacts
- Principal investigator: Deng-Chyang Wu, MD, PHD — Kaohsiung Medical University
- Study coordinator: Deng-Chyang Wu, MD, PHD
- Email: dechwu@yahoo.com
- Phone: 88673121101
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fecal transplant to help eradicate stubborn Helicobacter pylori infection
This study tests whether giving a fecal microbiota transplant can help people with Helicobacter pylori infection that has not responded to standard treatments.
-
Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori
We are testing whether a two-drug regimen of vonoprazan plus clarithromycin clears H. pylori in adults whose fecal PCR shows no clarithromycin resistance mutations.
-
P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection
This study tests whether using potassium-competitive acid blockers (P-CABs) in bismuth-containing quadruple therapy works better and is safe for adults with H. pylori infection.
-
Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children
This project will try adding bismuth to standard antibiotic and PPI treatment to see if it helps clear H. pylori and heal ulcers in children.
-
Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication
This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.
-
Potassium-competitive acid blocker versus proton pump inhibitor with bismuth quadruple therapy for H. pylori infection
This trial tests whether a potassium-competitive acid blocker works better than a proton pump inhibitor as part of bismuth quadruple therapy to cure H. pylori infection in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.