Effects of Super 13 Pro & Prebiotics on the Human Intestinal Microflora: a Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intestinal Microflora: Lactobacillus spp.
研究概览
简要总结
This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro & Prebiotics" or the control article, "The placebo without Super 13 Pro & Prebiotics" during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.
详细描述
This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro & Prebiotics" or the control article, "The placebo without Super 13 Pro & Prebiotics" three times a day during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The subjects took the test article, "Super 13 Pro & Prebiotics" or the control article, "The placebo without Super 13 Pro & Prebiotics" during the 4-week drug-intake period.
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 medications for gastrointestinal and metabolic diseases
- •Occurrences of severe diseases within 6 months, such as stroke, myocardial infarction, major trauma and surgery • Poor compliance for study protocol
结局指标
主要结局
Intestinal Microflora: Lactobacillus spp.
时间窗: 2nd, and 4th weeks
Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts.
Intestinal Microflora: Coliform
时间窗: 2nd, and 4th weeks
Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts.
Intestinal Microflora: Bifidobacterium spp.
时间窗: 2nd, and 4th weeks
Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts.
Intestinal Microflora: Clostridium perfringens
时间窗: 2nd, and 4th weeks
Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts.
次要结局
未报告次要终点