The Effect of Broccoli Sprout Extract and Probiotics on Proton Pump Inhibitor-based Triple Therapy for Eradication of Helicobacter Pylori: a Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 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
In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump inhibitor (PPI) and two antibiotics for one week. 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. In vitro study, we previously reported that a broccoli sprout extract containing sulforaphane may prevent lipid peroxidation in the gastric mucosa and play a cytoprotective role in Hp-induced gastritis. Also, several studies suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events. But, their effect for eradication of Hp is not yet conclusive. The aims of this prospective study is to investigate the efficacy of a broccoli sprout extract containing sulforaphane and probiotics for eradication of Hp, compared with standard triple therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Helicobacter pylori infected patients
- •Patients with active or healing gastric/duodenal ulcers
排除标准
- •prior Hp eradication therapy
- •previous gastric resection
- •previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics within 4 weeks of the study
- •Patients who were pregnant or lactating
研究组 & 干预措施
Triple Therapy
Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Esomeprazole (Drug)
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Probiotics (Drug)
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Esomeprazole (Drug)
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Amoxicillin (Drug)
Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Clarithromycin (Drug)
Broccoli
Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Broccoli (Dietary Supplement)
Broccoli
Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Esomeprazole (Drug)
Broccoli
Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Amoxicillin (Drug)
Broccoli
Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Clarithromycin (Drug)
Triple Therapy
Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Amoxicillin (Drug)
Triple Therapy
Esomeprazole + Amoxicillin + Clarithromycin
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Helicobacter pylori eradication
时间窗: 5 weeks after treatment initiation
Using the urea breath test
次要结局
未报告次要终点
研究者
Jung-Wook Kim
Clinical assistant professor
Kyunghee University Medical Center
