A Phase 4 interventional study of Rabeprazole and Bismuth potassium citrate in Helicobacter Pylori Infection, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Treatment
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.
Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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Exclusion Criteria:
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid and metronidazole 0.4 g qid for 14 days
Drug: Rabeprazole · Drug: Bismuth potassium citrate · Drug: Metronidazole
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 · Drug: Bismuth potassium citrate · Drug: Metronidazole · Drug: Amoxicillin
20mg bid
0.6g bid
0.4g qid
1g bid
Eradication rate of Helicobacter pylori
Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).
Time frame: At least 4 weeks after completion of therapy
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.
Time frame: 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.
Time frame: At least 4 weeks after completion of therapy
Adherence rate
Adherence was defined as poor when subjects took less than 80% of the total medication.
Time frame: At least 1 weeks after completion of therapy
Frequency of adverse events
Any possible adverse events during the 14-day treatment period were recorded.
Time frame: At least 1 weeks after completion of therapy
Plan to share: Yes — 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.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital