The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the treatment of Hard-to-treat Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. This study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Three kinds of antibiotics including amoxicillin,tetracycline, furazolidone, levofloxacin,clarithromycin,tinidazole,metronidazol
Qilu hosipital
Jinan, Shandong, China
Eradication rates
Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis. results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. of Helicobacter pylori infection. The ITT analysis includes all the 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: 6 month
The rate of adverse events happening
At the follow-up, adverse events complained by patients will be recorded by an independent researcher.Adverse events were graded as mild, moderate, or severe.
Time frame: 6 month
Compliance of patients
Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.
Time frame: 6 month
Xiuli Zuo, MD,PhD
CONTACT
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