NCT05718609

Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection

Efficacy of Quadruple Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests as First-line Treatment for Helicobacter Pylori Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 855 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Rabeprazole	proton-pump inhibitor (PPI)
DRUG	Colloidal Bismuth Pectin Granules	Gastric mucosal protective drug with anti-H. pylori effect
DRUG	Amoxicillin	Antibiotic for H. pylori eradication
DRUG	Furazolidone	Antibiotic for H. pylori eradication
DRUG	Clarithromycin	Antibiotic for H. pylori eradication

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2024-06-30
• First posted: 2023-02-08
• Last updated: 2023-05-15

Locations

1 site across 1 country: China