Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Simplified Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line Helicobacter Pylori Eradication
Overview
To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene detection.
Interventions
- Drug Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days
Participants receive vonoprazan 20 mg orally twice daily plus clarithromycin 500 mg orally twice daily for 14 consecutive days.
Primary outcome measures
- Eradication rate of H. pylori [Time frame: 4 weeks after the completion of treatment]
Secondary outcome measures (2)
- incidence of adverse reactions [Time frame: At the end of the 14-day medication period (Day 14)]
- Compliance [Time frame: At the end of the 14-day medication period (Day 14)]
Eligibility criteria
Inclusion criteria
- Aged 18-70 years;
- 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;
- Treatment-naïve individuals with no prior history of H. pylori eradication therapy.
Exclusion criteria
- Pregnant or lactating women
- Patients with a history of allergy to any drugs used in the eradication regimen
- Patients with severe systemic diseases or malignant tumors
- History of gastric resection surgery
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07439445 · 2026R0051-0002