The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results. After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated. According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows: Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,300
Use according to the drug combination options selected by each center.
Use according to the drug combination options selected by each center.
Use according to the drug combination options selected by each center.
Qilu hosipital
Jinan, Shandong, China
Eradication rate
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time frame: Immediately after follow-up check.
Rate of adverse reactions
Rate of adverse reactions
Time frame: Immediately after follow-up check.
Patient compliance
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Time frame: Immediately after follow-up check.
Cost-effectiveness index
Ratio of costs to effectiveness
Time frame: Immediately after follow-up check.
Xiuli Zuo, MD,PhD
CONTACT
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Use according to the drug combination options selected by each center.
Use according to the drug combination options selected by each center.
Use according to the drug combination options selected by each center.
Use according to the drug combination options selected by each center.