A Randomized, Controlled, Double-blind Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Eradication of Helicobacter pylori
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori.
详细描述
All patients included in this randomized controlled clinical trial will be selected according to strict inclusion and exclusion criteria. At the same time, the benefits and risks of participating in this trial will be explained to the patients before the start of the study, the patients' right to informed consent will be respected, and the informed consent will be signed. After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participants and investigator) in a 1:1:1:1 ratio to Lactobacillus plantarum (1.5×10^10 per time, three times daily) or Bacillus coagulans (1.5×10^10 per time, three times daily) or Lactobacillus plantarum + Bacillus coagulans (1.5×10^10 per time, three times daily) or placebo ( 15g per time, three times daily). At the same time, volunteers will be recruited from healthy people to perform the same treatment.
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, Care Provider, Investigator)
盲法说明
The person in charge of assigning patients to treatment groups does not know which treatments the patients receive, so they do not select patients in order of their own volition.
Patients themselves do not know what treatment they are receiving, so they do not change their compliance or reporting of symptoms.
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
- 是
入选标准
- •Aged 18-75 years.
- •Diagnosed by 13C-UBT within 2 weeks before entry.
排除标准
- •Previous treatment for H. pylori infection.
- •Administration of antibiotics, probiotics/prebiotics, PPIs, H2 receptor antagonists, bismuth preparations, laxatives, anti-diarrhoeals, and certain antimicrobial traditional Chinese medicines 4 weeks before.
- •Previous history of gastrointestinal surgery.
- •Severe or unstable diseases.
- •Pregnancy or lactation.
- •Alcoholics and drug abusers.
- •Staff of this trial.
结局指标
主要结局
Eradication of Helicobacter pylori
时间窗: The eighth week of the trial
All participants will have a 13C-urea breath test to see if their 13C value falls below the threshold for H. pylori eradication.
次要结局
- The condition of gastrointestinal symptoms in the third week(The third week of the trial.)
- The condition of gastrointestinal symptoms before the trial(Baseline)
- The condition of gastrointestinal symptoms in the second week(The second week of the trial.)
- The condition of gastrointestinal symptoms in the fourth week(The fourth week of the trial.)
- The condition of gastrointestinal symptoms in the first week(The first week of the trial.)