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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

855 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amoxicillin- and Clarithromycin-based BQT

rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days

Group Type ACTIVE_COMPARATOR

Rabeprazole

Intervention Type DRUG

proton-pump inhibitor (PPI)

Colloidal Bismuth Pectin Granules

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Clarithromycin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Clarithromycin medication history-based BQT

The clarithromycin medication history will be asked before the treatment and the therapy will be performed as follows: with clarithromycin medication history: rabeprazole 10mg bid, amoxicillin 1g bid, furazolidone 100mg bid, colloidal bismuth 200mg bid for 14 days; without clarithromycin medication history: rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days.

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

proton-pump inhibitor (PPI)

Colloidal Bismuth Pectin Granules

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Furazolidone

Intervention Type DRUG

Antibiotic for H. pylori eradication

Clarithromycin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Antimicrobial susceptibility tests-based BQT

Fecal molecular biology antimicrobial susceptibility tests will be performed before the treatment. The susceptibility of clarithromycin will be evaluated. The treatment regimen will be chosen according to the results of the antimicrobial susceptibility tests as follows: clarithromycin-sensitive: rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days; clarithromycin-resistant: rabeprazole 10mg bid, amoxicillin 1g bid, furazolidone 100mg bid, colloidal bismuth 200mg bid for 14 days.

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

proton-pump inhibitor (PPI)

Colloidal Bismuth Pectin Granules

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Furazolidone

Intervention Type DRUG

Antibiotic for H. pylori eradication

Clarithromycin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Interventions

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Rabeprazole

proton-pump inhibitor (PPI)

Intervention Type DRUG

Colloidal Bismuth Pectin Granules

Gastric mucosal protective drug with anti-H. pylori effect

Intervention Type DRUG

Amoxicillin

Antibiotic for H. pylori eradication

Intervention Type DRUG

Furazolidone

Antibiotic for H. pylori eradication

Intervention Type DRUG

Clarithromycin

Antibiotic for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Participants enrolled should meet the following criteria: (1) Participants aged 18-65 with no history of eradication treatment; (2) diagnosed as H. pylori infection by one or more of the following methodologies: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), the 13C-UBT, and/or fecal antigen; (3) were requested to undergo 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 before; and (4) voluntarily participated in the clinical trial and have signed the informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No