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NCT05718609
Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection
Conditions: Helicobacter Pylori Infection
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE4
Enrollment: 855
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Location: China
Summary
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.
Eligibility Criteria
Inclusion Criteria:Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹⁴C-urea breath test, HE stain, or bacterium cultureWith no historical treatment for helicobacter pylori infectionHave undergone an endoscopy before the eradication treatment if they have alarm symptoms, a family history of gastric cancer, or age over 40 years old without undergoing an endoscopy beforeExclusion Criteria:Administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor, and potassium-competitive acid blocker in 2 weeks prior to inclusionActive peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.With previous esophageal or gastric surgeryWith severe systemic diseases, major organs like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor, or other diseasesAllergy to any of the study drugsPregnancy or lactationParticipated in other research within 3 months, cannot express his/her own ideas correctly or cannot cooperate with the researcher
Source: ClinicalTrials.gov (NCT05718609). StuddyBuddy aggregates publicly available trial information.