Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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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: 4-6 weeks after the end of treatment, 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.

Official Title
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Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.

Conditions
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the Eradication Rates of Helicobacter Pylori

Intervention / Treatment
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* Drug: Rabeprazloe+bismuth+amoxicillin+clarithromycin
* Drug: Vonoprazan+amoxicillin+clarithromycin 14 days
* Drug: Vonoprazan+amoxicillin+clarithromycin 7 days
* Drug: Vonoprazan+tetracycline+furazolidone 14 days
* Drug: Vonoprazan+tetracycline+furazolidone 7 days
* Drug: Vonoprazan+amoxicillin+furazolidone 7 days
* Drug: Vonoprazan+amoxicillin+tetracycline 14 days
* Drug: Vonoprazan+amoxicillin 7 days
* Drug: Vonoprazan+amoxicillin 14 days


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days<br>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. | Drug: Rabeprazloe+bismuth+amoxicillin+clarithromycin<br>* 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.<br>|
| Experimental: Vonoprazan+amoxicillin+clarithromycin 14 days<br>14D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. | Drug: Vonoprazan+amoxicillin+clarithromycin 14 days<br>* VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.<br>|
| Experimental: Vonoprazan+amoxicillin+clarithromycin 7 days<br>7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. | Drug: Vonoprazan+amoxicillin+clarithromycin 7 days<br>* VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.<br>|
| Experimental: Vonoprazan+tetracycline+furazolidone 14 days<br>14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. | Drug: Vonoprazan+tetracycline+furazolidone 14 days<br>* VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.<br>|
| Experimental: Vonoprazan+tetracycline+furazolidone 7 days<br>7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. | Drug: Vonoprazan+tetracycline+furazolidone 7 days<br>* VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.<br>|
| Experimental: Vonoprazan+amoxicillin+furazolidone 7 days<br>7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; F: furazolidone 100mg bid. | Drug: Vonoprazan+amoxicillin+furazolidone 7 days<br>* hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.<br>|
| Experimental: Vonoprazan+amoxicillin+tetracycline 14 days<br>7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid. | Drug: Vonoprazan+amoxicillin+tetracycline 14 days<br>* hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.<br>|
| Experimental: Vonoprazan+amoxicillin 7 days<br>7D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid. | Drug: Vonoprazan+amoxicillin 7 days<br>* hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.<br>|
| Experimental: Vonoprazan+amoxicillin 14 days<br>14D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid. | Drug: Vonoprazan+amoxicillin 14 days<br>* hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication 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). | Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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; | 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. | 14 days of treatment, and 28 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori ; Vonoprazan