The Efficacy of Lactobacillus Acidophilus and Lactobacillus Rhamnosus in the Modification of Gut Microbiota and Reduction of Helicobacter Pylori Bacterial Load- a Double Blind, Placebo Controlled, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reduction of bacterial load of H. pylori
研究概览
简要总结
We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial.
详细描述
Subjects: Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial. We will screen 150 subjects and it is estimated that 40 H. pylori infected subjects will be eligible. Eligible subjects will be randomized to receive probiotic (Lactobacillus acidophilus and Lactobacillus rhamnosus) or placebo, one pack twice daily, for 28 days. The primary outcome was the reduction in H. pylori load of greater than 20% than baseline. The secondary outcome was the impact of the probiotic on the gut microbiota and the adverse effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial
排除标准
- •history of gastrectomy and colectomy
- •severe underlying illness, such as malignancy, ESRD, liver failure, etc
- •allergy to probiotics
- •symptomatic patients who need PPI, antibiotics, or other probiotics
- •pregnancy and lactating women
- •unable to cooperate with the protocol
结局指标
主要结局
Reduction of bacterial load of H. pylori
时间窗: after 4 weeks of treatment
次要结局
- changes in gut microbiota(after 4 weeks of treatment)
- adverse effects(4 weeks)
研究者
Statistical Center, NTUHCTC
Attending physician
National Taiwan University Hospital