The Study of Adding Bismuth on Susceptibility-based Regimen Strategy to Enhance the Eradication Rate for Multi-resistant H. Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The eradication rate of H. pylori
研究概览
简要总结
The goal of this clinical trial is to learn if the 14-day susceptibility-guided bismuth quadruple therapy works to treat multiple drug resistant Helicobacter pylori (H. pylori) in adults. It will also learn about the adverse effects of bismuth quadruple therapy. The main questions it aims to answer are:
- Does 14-day susceptibility-guided bismuth quadruple therapy higher the eradication rate?
- What medical problems do participants have when taking 14-day susceptibility-guided bismuth quadruple? Researchers will record 14-day susceptibility-guided bismuth quadruple to see if 14-day susceptibility-guided bismuth quadruple works to treat multiple drug resistant H. pylori.
Participants will:
- Take susceptibility-guided bismuth quadruple every day for 14 days
- Visit the clinic once 4-6 weeks for checkups and tests
- Keep a diary of their symptoms during taking susceptibility-guided bismuth quadruple
详细描述
Helicobacter pylori (H. pylori) infection is the major culprit of dyspeptic symptoms, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma.
The antibiotic resistance of H. pylori infection is an emerging issue. Moreover, amoxicillin-resistant H. pylori strains increased recently. The amoxicillin resistance rates were 9% in Asia and up to 39% in South America.
Susceptibility-guided therapy is superior to empiric therapy in 2nd-line therapy. After twice eradication failure, H. pylori culture for susceptibility test is strongly recommended, which guide clinician to choose appropriate susceptibility-based therapy. The multiple drug resistant rates may be higher in patients who fail two or more eradication therapy; thus, susceptibility-guided therapy is currently the consensus recommendation for 3rd-line H. pylori eradication. Bismuth quadruple therapy could overcome either clarithromycin or metronidazole resistant strains. Several evidences of clinical randomized-controlled trials demonstrated that adding bismuth as the first line therapeutic regimen can capture additional 30%-40% successful eradication rate for the resistant strain, further contributing to the overall eradication rate.
Accordingly, the aim of our study was to validate the susceptibility-guided bismuth quadruple therapy in patients with multiple drug resistant H. pylori infection in terms of efficacy and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H. pylori-infected with treatment experience with at least one course of eradication failure
- •H. pylori-infected with treatment naïve but having multiple-drug resistant H. pylori (>= three antibiotics)
- •H. pylori infection confirmed by H. pylori culture
排除标准
- •Previous allergic reactions to regimens, including amoxicillin, bismuth subcitrate, esomeprazole, metronidazole, rifabutin, and tetracycline,
- •Severe comorbidities,
- •Chronic kidney disease with estimated glomerular filtration rate < 60 ml/min/1.73 m2,
- •Pregnant or breastfeeding women.
- •Dual-resistant H. pylori infection
- •Mono-resistant H. pylori infection
- •All susceptible H. pylori infection
- •Positive RUT but negative H. pylori culture
- •Negative RUT and negative H. pylori culture
- •Decline to participate
研究组 & 干预措施
Bismuth-based susceptibility-guided treatment
Participants who have triple- or quadruple-drug resistant H. pylori infection are enrolled. Participants receive one of the four regimens based on susceptibility test.
干预措施: Bismuth-based susceptibility-guided treatment (Drug)
结局指标
主要结局
The eradication rate of H. pylori
时间窗: From enrollment to the end of treatment at 6-8 weeks
The investigators define successful eradication as a negative 13C-urea breath test or a negative H. pylori stool antigen test at 4 to 6 weeks after the completion of H. pylori eradication and discontinuation of antibiotics and proton pump inhibitors. The eradication rates are determined by intention-to-treat and per-protocol analyses. The intention-to-treat analysis evaluates all enrolled participants. The per-protocol analysis evaluates those who take \>= 80% of the study medications and receive post-treatment 13C-urea breath test or an H. pylori stool antigen test. The successful rate is represented with a percentage (%).
次要结局
- Adverse effects(From enrollment to the end of treatment at 2 weeks)
- Adherence to medications(From enrollment to the end of treatment at 2 weeks)