High-dose Dual Therapy With Different Administration Frequencies

Study Overview
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Brief Summary
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This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Detailed Description
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According to relevant literature research, amoxicillin TID groups (including before meal group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0 TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital. The three groups were treated for 14 days respectively, and 13C urea breath test was performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.

Official Title
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Randomized and Controlled Clinical Study of High-dose Dual Therapy With Different Administration Frequencies in the Treatment of Helicobacter Pylori

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: vonoprazan
* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability and willingness to participate in the study and to sign and give informed consent Confirmed H. pylori infection Exclusion Criteria: Pregnant and lactating women; History of gastrointestinal malignancies; History of previous subtotal gastrectomy; Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc; History of hematological diseases People who are allergic to drugs; The guardian or patient refused to join the group; Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors; No legal capacity or poor self-knowledge administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dual therapy A<br>Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc | Drug: vonoprazan<br>* Potassium competitive acid blocker<br>Drug: Amoxicillin<br>* Antibiotics for H. pylori eradication<br>|
| Experimental: dual therapy B<br>Vonoprazan 20mg bid ac and amoxicillin 1g tid pc | Drug: vonoprazan<br>* Potassium competitive acid blocker<br>Drug: Amoxicillin<br>* Antibiotics for H. pylori eradication<br>|
| Experimental: dual therapy C<br>Vonoprazan 20mg bid ac and amoxicillin 1g tid ac | Drug: vonoprazan<br>* Potassium competitive acid blocker<br>Drug: Amoxicillin<br>* Antibiotics for H. pylori eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-rea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value). | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events | The subjects were asked to record side effects and discomfort during treatment and actual drug administration. | Within 7 days after completion of therapy | 
| Compliance rate | Compliance was defined as poor when they had taken less than 80% of the total medication | Within 7 days after completion of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Dual Therapy