Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori
Official title: Efficacy and Safety of Simplified Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line Helicobacter Pylori Eradication
Run by Peking University First Hospital · NCT07439445 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | April 25, 2026 |
| Main results expected | February 13, 2027 |
| Study ends | February 13, 2027 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07439445 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–70 with confirmed H. pylori infection who have not received prior eradication therapy and whose fecal PCR shows no clarithromycin resistance mutations are ideal candidates.
✕Probably not a fit
Patients with clarithromycin-resistant strains, prior H. pylori treatment, allergy to the study drugs, recent use of antibiotics/acid blockers, pregnancy or lactation, severe systemic disease, or prior gastric surgery are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial uses fecal PCR to screen for clarithromycin resistance mutations and, if absent, gives participants vonoprazan 20 mg twice daily plus clarithromycin 500 mg twice daily for 14 days as first-line therapy. Eligible participants are treatment-naïve adults with confirmed H. pylori by 13C-UBT and fecal PCR. Primary outcomes include eradication efficacy, safety, and treatment compliance. The study is conducted at Peking University First Hospital in Beijing as a single-center interventional protocol.
Why it matters
Potential benefit: If successful, this approach could allow a simpler two-drug first-line option for patients without clarithromycin-resistant H. pylori, improving cure rates and adherence while avoiding unnecessary antibiotics.
How similar studies have gone: Vonoprazan-based regimens have shown higher eradication rates than PPIs and resistance-guided therapy has improved outcomes, but using fecal PCR to guide clarithromycin selection is a relatively new approach with limited large-scale evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-70 years; 2. Positive results for both ¹³C-urea breath test (¹³C-UBT) and fecal polymerase chain reaction (PCR), confirming Helicobacter pylori infection, with a clinical indication for H. pylori eradication as judged by the physician; 3. Treatment-naïve individuals with no prior history of H. pylori eradication therapy. Exclusion Criteria: 1. Pregnant or lactating women 2. Patients with a history of allergy to any drugs used in the eradication regimen 3. Patients with severe systemic diseases or malignant tumors 4. History of gastric resection surgery 5. Recent use of antibiotics or bismuth salts (within 4 weeks), H₂-receptor antagonists, proton pump inhibitors (PPIs), or Potassium-competitive acid blockers(P-CABs) (within 2 weeks).
Where it's running
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Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Weihong Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Weihong Wang, MD, PhD
- Email: wangweihong2581@163.com
- Phone: 13041171610
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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.