Helicobacter Pylori Infection
Conditions
Brief summary
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
DRUGVonoprazan 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.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate of H. pylori | 4 weeks after the completion of treatment | H. pylori eradication rate assessed by¹³C-urea breath test at 4 weeks after the completion of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of adverse reactions | At the end of the 14-day medication period (Day 14) | The incidence of adverse reactions refers to the proportion of participants who experience any adverse reactions related to the study drugs (vonoprazan and clarithromycin) during the 14-day medication period. |
| Compliance | At the end of the 14-day medication period (Day 14) | Medication compliance rate (proportion of participants with good compliance, defined as compliance rate ≥ 80%). |
Countries
China
Contacts
CONTACTWeihong Wang, MD, PhD
CONTACTMeng Li
PRINCIPAL_INVESTIGATORWeihong Wang, MD, PhD
Peking University First Hospital
Outcome results
None listed