14-day PCAB-based High-dose Dual Therapy and14-day PCAB-based Triple Therapy vs 14-day PPI-based Reverse Hybrid Therapy

Study Overview
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Brief Summary
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Test for Helicobacter pylori. The test items include urease test, histology, bacterial culture, serology, and urea breath test. At least two positive results can be used to confirm the diagnosis. To ensure that the research results are not artificially distorted, this trial is a randomized study. Random allocation (which means that the subjects will use the random number table generated by a computer similar to the lottery to determine the treatment group) accept one of the following schemes (1:1:1).

Detailed Description
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Helicobacter pylori (H.pylori) infect more than 50% of humans globally. This study were (1) to test whether the efficacies of 14-day PCAB-based high-dose dual therapy and 14-day PPI-based reverse hybrid therapy can achieve a higher eradication rate than 14-day PCAB-based triple therapy in the first-line treatment of H pylori infection, (2) to compare the eradication rates of 14-day PCAB-based and PPI-based bismuth quadruple therapies in the second-line treatment of H pylori infection, and (3) to examine the impacts of antibiotic resistance of H pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H pylori treatments.

Official Title
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14-day PCAB-based and Reverse Hybrid Therapy Fro Helicobacter Pylori

Conditions
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Helicobacter Pylori Eradication

Intervention / Treatment
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* Drug: Vonoprazan and Amoxicillin
* Drug: Vonoprazan, Amoxicillin and Clarithromycin
* Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects infected with Helicobacter pylori. Exclusion Criteria: Those who have ever received Helicobacter pylori sterilization treatment. Those who are allergic to the drugs used in this research. Those who have had stomach surgery. Those with severe liver cirrhosis or uremia or malignant tumors. Women who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: 14-day vonoprazan high-dose two-in-one therapy 14-day vonoprazan triple therapy 14th Rabeprazole reverse mixed therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 14-day vonoprazan high-dose two-in-one therapy<br>vonoprazan 20mg bid and amoxicillin 750mg qid | Drug: Vonoprazan and Amoxicillin<br>* 14-day vonoprazan high-dose two-in-one therapy<br>|
| Active Comparator: 14-day vonoprazan triple therapy<br>vonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid | Drug: Vonoprazan, Amoxicillin and Clarithromycin<br>* 14-day vonoprazan triple therapy<br>|
| Active Comparator: 14th Rabeprazole reverse mixed therapy<br>first 7 days rabeprazole 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid and metronidazole 500mg bid Next 7 days rabeprazole 20mg bid and amoxicillin 1gm bid | Drug: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole<br>* 14th Rabeprazole reverse mixed therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of Helicobacter pylori | Evaluate eradication outcome by 13C uear breath test | 6 week after finishing study drugs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions | drugs | 2weeks after finishing study drugs |