The researchers collect H.pylori-positive patients who need rescue therapy from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth 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 and patient compliance of each group.
The researchers collect H.pylori-positive patients who need rescue therapy 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 dose and frequency of tetracycline 500mg tid or qid of bismuth 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 and patient compliance of each group were calculated. According to the dose and frequency of tetracycline, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows: Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Amoxicillin 1000mg bid +Tetracycline 500mg tid +Bismuth+Esomeprazole 40mg bid
Amoxicillin 1000mg bid +Tetracycline 500mg qid +Bismuth+Esomeprazole 40mg bid
Department of Gastroenterology,QiLu Hospital,Shandong University
Jinan, Shandong, China
RECRUITINGEradication 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: through study completion, an average of 1.5 years
Rate of adverse reactions
Rate of adverse reactions
Time frame: through study completion, an average of 1.5 years
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: through study completion, an average of 1.5 years
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