Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Modification of the Composition of the Intestinal Microflora: Bifidobacterium
研究概览
简要总结
Fermented milk is a popular drink. Recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. Lactobacillus casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced immune responses in allergic rhinitis, altering fermentation patterns in the small bowel, prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the human intestinal microflora.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers and willing to give voluntary written informed consent
排除标准
- •Major systemic disease
- •Pregnancy, parturient and feeding woman, or expect to be pregnant
- •Abnormal liver function
- •Abnormal renal function
- •Abnormal gastrointestinal function
- •Take medication for gastrointestinal function
- •Stroke, myocardial infarction,
- •Poor compliance for study protocol
结局指标
主要结局
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
时间窗: week 0, 1, 2, 3, 4, 5, 6.
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
时间窗: week 0, 1, 2, 3, 4, 5, 6.
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Clostridium perfringens was cultured.Bacterial colonies were counted.
次要结局
- Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota(at week 0, 1, 2, 3, 4, 5, 6)