This study aims to evaluate the efficacy and safety of 14-day quadruple therapy based on fecal molecular antimicrobial susceptibility tests for the first-line eradication of H. pylori infection, thus, providing more evidence to inform the value of fecal antimicrobial susceptibility tests in the first-line treatment of H. pylori infection.
The eradication rate of H. pylori is decreasing year by year due to the occurrence of bacterial resistance, especially clarithromycin, one of the most widely-used antimicrobials against H. pylori. Understanding antibiotic resistance before treatment may be the main determinant of the successful eradication of H. pylori. Nevertheless, due to the invasive examination of sampling, the economy-benefit ratio, and the harsh cultivation conditions, traditional antimicrobial susceptibility test is rarely used before first-line eradication treatment in the real world. As an alternative, faster and simpler molecular methods applied to fecal samples obviate the need for endoscopy and provide the possibility to popularize the antimicrobial susceptibility tests catering to initial treatment. This study aims to explore the efficacy, safety, and economic benefits of the first-line therapy for H. pylori guided by fecal antimicrobial susceptibility tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
855
proton-pump inhibitor (PPI)
Gastric mucosal protective drug with anti-H. pylori effect
Antibiotic for H. pylori eradication
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGHelicobacter pylori Eradication Rate
Helicobacter pylori Eradication will be determined by 13C-urea breath test or 14C-urea breath test six to eight weeks after completion of the medication.
Time frame: Six to eight weeks after completion of the medication
Rate of Adverse Drug Reaction(ADR)
Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).
Time frame: Within 7 days after completion of therapy
Compliance Rate
Compliance was defined as poor when they had taken less than 80% of the total medication.
Time frame: Within 7 days after completion of therapy
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Antibiotic for H. pylori eradication
Antibiotic for H. pylori eradication