Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Shanghai Zhongshan Hospital

Overview

This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the treatment of Helicobacter pylori in patients with chronic gastritis. This study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. At the same time, it will provide reference for the reasonable pricing of H.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Helicobacter Pylori Infection

Interventions

EsomeprazoleDRUG

20mg bid

Bismuth potassium citrateDRUG

0.6g bid

MetronidazoleDRUG

0.4g qid

Clarithromycin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF). * 18-75 years old on the day of signing the ICF. * Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test. Exclusion Criteria: * Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. * Subjects or guardians refused to participate in the trial. * Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment. * Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment. * Pregnant or lactating women. * Active peptic ulcer. * allergic to drugs used in the trial. * any other circumstances that are not suitable for recruitment.

Locations (3)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Eradication rate of Helicobacter pylori

Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).

Time frame: 6 weeks

Secondary Outcomes

Eradication rate of Helicobacter pylori resistant strains

Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.

Time frame: 6 weeks

Eradication rate of Helicobacter pylori susceptible strains

Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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