Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment

Study Overview
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Brief Summary
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This randomized controlled clinical trial will compare the eradication efficacy of bismuth-metronidazole triple therapy (PPI+bismuth+ metronidazole) with that of bismuth-metronidazole quadruple therapy (PPI+bismuth+ metronidazole+ amoxicillin) for Helicobacter pylori first-line 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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Bismuth-Metronidazole Triple Versus Quadruple Therapy for Helicobacter Pylori First-line Treatment: A Randomized Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Rabeprazole
* Drug: Bismuth potassium citrate
* Drug: Metronidazole
* Drug: Amoxicillin


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. Have not received Helicobacter pylori eradication treatment before. Exclusion Criteria: Have received Hp eradication treatment. 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, PPI 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMT group<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid and metronidazole 0.4 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 qid<br>|
| Active Comparator: BMQ group<br>Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and amoxicillin 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 qid<br>Drug: Amoxicillin<br>* 1g bid<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). | At least 4 weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori metronidazole-resistant strains | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The strains with minimal inhibitory concentration (MIC) value of metronidazole >8 μg/ml were defined as resistant strains. | At least 4 weeks after completion of therapy | 
| Eradication rate of Helicobacter pylori metronidazole-susceptible strains | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The strains with metronidazole MIC value <=8 μg/ml were defined as susceptible strains. | At least 4 weeks after completion of therapy |