The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are: * Main indicators: the eradication rate of Helicobacter pylori for eradication. * Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,404
PBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.
hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.
hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
Ying han
Xi'an, Shaanxi, China
RECRUITINGEradication rate of Helicobacter pylori
Evaluated by 13C/14C-urea Breath test results and/or monoclonal faecal antigen test results were assessed as negative for successful eradication and positive for negative for successful eradication, positive for failed eradication 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication and positive for (assessed by 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication, positive for failure).
Time frame: Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment
Incidence of adverse effects
According to the requirements of the "Drug Clinical Trial Management Code", the observation is carried out, and the adverse reactions of the patients during the administration of the drug are recorded. The severity, or intensity, of an AE refers to the extent to which an AE affects the subject' s daily activities. The intensity of the AE will be rated as mild (discomfort without influencing daily activities), moderate (discomfort partially influencing daily activities), or severe (discomfort with severe interruption with daily activities).
Time frame: 14 days of treatment, and 28 days after treatment
Treatment compliance
Adherence was analysed according to medication possession ratio (MPR), where taking less than 80% of study drug during any evaluation period or failure to review was considered poor adherence;
Time frame: 7 or 14 days of treatment
Symptom relief rate
Patients were classified as no change, remission, cure, or exacerbation based on changes in clinical symptoms.
Time frame: 14 days of treatment, and 28 days after treatment
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