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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMT group | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid and metronidazole 0.4 g qid for 14 days |
|
| BMQ group | Active Comparator | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and amoxicillin 1 g bid for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole | Drug | 20mg bid |
| |
| Bismuth potassium citrate |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate | Adherence was defined as poor when subjects took less than 80% of the total medication. | At least 1 weeks after completion of therapy |
| Frequency of adverse events | Any possible adverse events during the 14-day treatment period were recorded. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Chen, MD | Contact | 86-17811921405 | chenqimd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Taotao Liu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Taotao Liu at liu.taotao@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
Beginning 6 months and ending 5 years after the trial results were published.
All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D008795 | Metronidazole |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
0.6g bid |
|
| Metronidazole | Drug | 0.4g qid |
|
| Amoxicillin | Drug | 1g bid |
|
| 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 |
| At least 1 weeks after completion of therapy |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |