Helicobacter Pylori Eradication and Follow-up

Study Overview
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Brief Summary
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This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

Official Title
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Helicobacter Pylori Eradication and Follow-up in Zhongshan Hospital

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Rabeprazole
* Drug: Bismuth potassium citrate
* Drug: Metronidazole
* Drug: Clarithromycin
* Drug: Levofloxacin
* Drug: Amoxicillin
* Drug: Metronidazole
* Drug: Doxycycline
* Drug: Tetracycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF). 18-75 years old on the day of signing the ICF. Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test. Exclusion Criteria: Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. Subjects or guardians refused to participate in the trial. Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment. Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment. Pregnant or lactating women. Active peptic ulcer. allergic to drugs used in the trial. any other circumstances that are not suitable for recruitment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RBCL<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Clarithromycin<br>* 0.5g bid<br>Drug: Levofloxacin<br>* 0.5g qd<br>|
| Experimental: RBLM<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Metronidazole<br>* 0.4g qid<br>Drug: Levofloxacin<br>* 0.5g qd<br>|
| Experimental: RBCM<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Metronidazole<br>* 0.4g qid<br>Drug: Clarithromycin<br>* 0.5g bid<br>|
| Experimental: RA<br>Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Amoxicillin<br>* 1g tid<br>|
| Experimental: RAB<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Amoxicillin<br>* 1g tid<br>|
| Experimental: RAM<br>Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Metronidazole<br>* 0.4g qid<br>Drug: Amoxicillin<br>* 1g tid<br>|
| Experimental: RBAM<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Metronidazole<br>* 0.4g qid<br>Drug: Amoxicillin<br>* 1g tid<br>|
| Experimental: RBAM4<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Amoxicillin<br>* 1g tid<br>Drug: Metronidazole<br>* 0.4g tid<br>|
| Experimental: RBDM<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Metronidazole<br>* 0.4g tid<br>Drug: Doxycycline<br>* 0.1g bid<br>|
| Active Comparator: RBTM<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days | Drug: Rabeprazole<br>* 20mg bid<br>Drug: Bismuth potassium citrate<br>* 0.6g bid<br>Drug: Metronidazole<br>* 0.4g tid<br>Drug: Tetracycline<br>* 0.5g qid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori resistant strains | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method. | 6 weeks | 
| Eradication rate of Helicobacter pylori susceptible strains | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method. | 6 weeks |