NCT04424329已完成不适用
Effect of a Specific Blend of Fibers and Probiotics on the Microbiome
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Minimizing microbiota composition change
研究概览
简要总结
The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent signed
- •Adult men and women aged 18 to 45 years
- •Healthy based on the medical screening visit and medical questionnaire
- •BMI in the range of 18.5 to 29.9 kg/m2.
排除标准
- •Known food allergy and intolerance
- •Currently participating in another clinical trial or research project
- •Fewer than 5 spontaneous bowel movements per week on average
- •Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
- •Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
- •Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment
- •Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents
- •Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)
- •Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
- •Artificially sweetened beverage intake higher than 1000 ml/ per day
- •Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.
- •Subject having a hierarchical or family link with the research team members.
结局指标
主要结局
Minimizing microbiota composition change
时间窗: Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)
Shotgum metagenomics
次要结局
- Increased intestinal microbiota diversity(Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge))
- Increased microbiota gene richness(Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge))
- Gut comfort(Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge))
研究者
研究点 (2)
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