Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori

Efficacy and Safety of Simplified Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line Helicobacter Pylori Eradication

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07439445 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions Helicobacter Pylori Infection