Efficacy of Quadruple Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests as First-line Treatment for Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 855
- 试验地点
- 1
- 主要终点
- Helicobacter pylori Eradication Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Potential participants will be screened on the following exclusion criteria: (1) Participants had a history of using antibiotics or bismuth within four weeks or acid inhibitor (including H2 receptor antagonist (H2RA), proton-pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB)) within two weeks before inclusion; (2) had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction; (3) had a history of esophagectomy or gastrectomy; (4) had an allergy to any study drug; (5) were pregnant or breastfeeding; (6) had a history of alcohol abuse or drug addiction; (7) existence of mental illness; or (8) without self-judgment ability.
研究组 & 干预措施
Amoxicillin- and Clarithromycin-based BQT
rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days
干预措施: Colloidal Bismuth Pectin Granules (Drug)
Amoxicillin- and Clarithromycin-based BQT
rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days
干预措施: Rabeprazole (Drug)
Amoxicillin- and Clarithromycin-based BQT
rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days
干预措施: Amoxicillin (Drug)
Amoxicillin- and Clarithromycin-based BQT
rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days
干预措施: Clarithromycin (Drug)
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.
干预措施: Rabeprazole (Drug)
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.
干预措施: Colloidal Bismuth Pectin Granules (Drug)
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.
干预措施: Amoxicillin (Drug)
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.
干预措施: Furazolidone (Drug)
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.
干预措施: Clarithromycin (Drug)
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.
干预措施: Rabeprazole (Drug)
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.
干预措施: Colloidal Bismuth Pectin Granules (Drug)
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.
干预措施: Amoxicillin (Drug)
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.
干预措施: Furazolidone (Drug)
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.
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Helicobacter pylori Eradication Rate
时间窗: Six to eight weeks after completion of the medication
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.
次要结局
- Rate of Adverse Drug Reaction(ADR)(Within 7 days after completion of therapy)
- Compliance Rate(Within 7 days after completion of therapy)