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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGEradication 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
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