The Evaluation of Saccharomyces Boulardii Sachets Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori: a Prospective, Multi-Center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication
研究概览
简要总结
The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therap.
详细描述
In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Several studies previously suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events with PPI-based triple therapy. But, their effect for eradication of Hp is not yet conclusive. And the experiments now available about efficacy of Saccharomyces Boulardii were mainly combined with triple therapy. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Helicobacter pylori infected patients
- •13C DOB>8
- •age 22~65
排除标准
- •prior Hp eradication therapy including amoxicillin and clarithromycin
- •previous gastric resection
- •allergic to the drugs used in this study
- •previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
- •Patients who were pregnant or lactating
- •Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy，diabete mellitus, hypertension...) effect the evaluation of this study
- •Can't express the complaint correctly
研究组 & 干预措施
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Saccharomyces boulardii (Drug)
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Esomeprazole (Drug)
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Amoxicillin (Drug)
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Clarithromycin (Drug)
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Bismuth potassium citrate (Drug)
Quadruple Therapy
Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Esomeprazole (Drug)
Quadruple Therapy
Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Amoxicillin (Drug)
Quadruple Therapy
Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Clarithromycin (Drug)
Quadruple Therapy
Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
干预措施: Bismuth potassium citrate (Drug)
结局指标
主要结局
Helicobacter pylori eradication
时间窗: 6 weeks after treatment initiation
to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.
次要结局
- Incidence of adverse events(2 weeks and 4-12 weeks after treatment initiation)
研究者
Bin Cheng
Professor
Tongji Hospital