the Eradication Rates of Helicobacter Pylori
Conditions
Keywords
Helicobacter pylori ; Vonoprazan
Brief summary
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.
Interventions
DRUGRabeprazloe+bismuth+amoxicillin+clarithromycin
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.
DRUGVonoprazan+amoxicillin+clarithromycin 14 days
VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
DRUGVonoprazan+amoxicillin+clarithromycin 7 days
VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
DRUGVonoprazan+tetracycline+furazolidone 14 days
VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
DRUGVonoprazan+tetracycline+furazolidone 7 days
VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
DRUGVonoprazan+amoxicillin+furazolidone 7 days
hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.
DRUGVonoprazan+amoxicillin+tetracycline 14 days
hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.
DRUGVonoprazan+amoxicillin 7 days
hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
DRUGVonoprazan+amoxicillin 14 days
hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.
Exclusion criteria
* Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate of Helicobacter pylori | Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse effects | 14 days of treatment, and 28 days after treatment | 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). |
| Treatment compliance | 7 or 14 days of treatment | 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; |
| Symptom relief rate | 14 days of treatment, and 28 days after treatment | Patients were classified as no change, remission, cure, or exacerbation based on changes in clinical symptoms. |
Countries
China
Outcome results
None listed