14-day vonoprazan-based dual therapy versus quadruple therapy for H. pylori eradication
Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
This study will test whether a 14-day vonoprazan plus amoxicillin treatment clears H. pylori as well as two different 14-day vonoprazan-based quadruple regimens in adults with H. pylori infection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 372 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Locations | 2 sites (Jinan, Shandong and 1 other locations) |
| Trial ID | NCT07179159 on ClinicalTrials.gov |
What this trial studies
This multicentre, randomized non-inferiority trial will enroll adults aged 18–70 with confirmed H. pylori infection and no prior eradication therapy. Participants will be randomized to 14 days of vonoprazan–amoxicillin dual therapy or to one of two 14-day vonoprazan-based quadruple regimens that add either levofloxacin and bismuth or clarithromycin and bismuth. The primary outcome is H. pylori eradication rate measured after treatment, and secondary outcomes include adverse events and patient adherence. Sites are in Shandong, China, and standard diagnostic tests such as the 13C-urea breath test and confirmatory stool, urease, or histology are used for enrollment and outcome confirmation.
Who should consider this trial
Good fit: Adults 18–70 with laboratory-confirmed H. pylori infection who have not received prior eradication therapy and who do not have severe organ dysfunction or pregnancy are suitable candidates.
Not a fit: Patients with severe hepatic or renal disease, active gastrointestinal bleeding, recent use of antibiotics/bismuth/acid-suppressing agents, prior H. pylori treatment, pregnancy or lactation, or inability/unwillingness to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the dual regimen could offer a simpler, lower-drug treatment with similar eradication rates and fewer side effects.
How similar studies have performed: Previous studies, particularly from East Asia, have reported promising eradication rates for vonoprazan–amoxicillin dual therapy, though outcomes vary by regional antibiotic resistance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-70 years, male or female 2. Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue) 3. No prior Helicobacter pylori eradication therapy Exclusion Criteria: 1. Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours 2. Active gastrointestinal bleeding 3. History of upper gastrointestinal surgery 4. History of drug hypersensitivity 5. Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks 6. Pregnant or lactating women 7. Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use 8. Individuals unable or unwilling to provide informed consent
Where this trial is running
Jinan, Shandong and 1 other locations
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
- Qilu Hospital of Shandong University — Jinan, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Yueyue Li
- Email: lyynqj@126.com
- Phone: +8618560089751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.