Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BMT group Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid and metronidazole 0.4 g qid for 14 days |
Drug: Rabeprazole
20mg bid
Drug: Bismuth potassium citrate
0.6g bid
Drug: Metronidazole
0.4g qid
|
| Active Comparator: BMQ group 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
20mg bid
Drug: Bismuth potassium citrate
0.6g bid
Drug: Metronidazole
0.4g qid
Drug: Amoxicillin
1g bid
|
Outcome Measures
Primary Outcome Measures
- Eradication rate of Helicobacter pylori [At least 4 weeks after completion of therapy]
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).
Secondary Outcome Measures
- Eradication rate of Helicobacter pylori metronidazole-resistant strains [At least 4 weeks after completion of therapy]
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.
- Eradication rate of Helicobacter pylori metronidazole-susceptible strains [At least 4 weeks after completion of therapy]
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.
Other Outcome Measures
- Adherence rate [At least 1 weeks after completion of therapy]
Adherence was defined as poor when subjects took less than 80% of the total medication.
- Frequency of adverse events [At least 1 weeks after completion of therapy]
Any possible adverse events during the 14-day treatment period were recorded.
Eligibility Criteria
Criteria
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.
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Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
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Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
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Pregnant or lactating women.
-
Active peptic ulcer.
-
allergic to drugs used in the trial.
-
any other circumstances that are not suitable for recruitment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital, Fudan University | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Principal Investigator: Taotao Liu, MD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B2020-261