NCT03134469已完成不适用
Efficacy of Probiotics on Excessive Gas Accumulation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Breath hydrogen
研究概览
简要总结
Efficacy of probiotics on excessive gas accumulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 18-50 years, at the time of signing the informed consent.
- •Willing and able to give written informed consent for participating in the study
- •Willing to comply with all study procedures
排除标准
- •Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
- •Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
- •Known gluten intolerance, lactose intolerance, milk protein allergy
- •Vegetarian diet
- •Intake of antibiotics within four weeks prior to the start of the study
- •Hypersensitivity to any of the ingredients in the investigational product (IP)
- •Regular intake of probiotics within four weeks prior to the start of the study
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
- •Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
研究组 & 干预措施
Probiotics
Experimental
Intake of a probiotic capsule once daily
干预措施: Probiotic supplement (Dietary Supplement)
Placebo
Placebo Comparator
Intake of a placebo capsule once daily
干预措施: Placebo supplement (Dietary Supplement)
结局指标
主要结局
Breath hydrogen
时间窗: 4 hours
The level of breath hydrogen is measured after a challenge with lactulose
次要结局
未报告次要终点
研究者
研究点 (2)
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