The purpose of this study is to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.
Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
Furazolidone-tetracycline-containing quadruple regimens
tinidazole-tetracycline-containing quadruple regimens
Qilu hospital
Jinan, Shandong, China
RECRUITINGEradication rates in 2 groups
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: 12months
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
Time frame: 12months
The rate of adverse events happening
Similarly, adverse events will also be measured by the Likert scale.
Time frame: 12months
The rate of good compliance
The rate of good compliance
Time frame: 12months
Xiuli Zuo, MD,PhD
CONTACT
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