Randomized, Two Arm, Parallel Group, Open Label, Single Center Prospective Study of the Fecal Recovery of Lactobacillus Rhamnosus GG (LGG) and Bifidobacterium Animalis Subspecies Lactis (BB-12) in Healthy Humans Following Daily Consumption of ProNutrients Probiotic Powder Sachet
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 3 weeks
研究概览
简要总结
The main hypothesis of this study is that there will be a significant increase of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy humans following daily consumption of a probiotic supplement containing these specific strains of probiotic bacteria.
详细描述
To demonstrate recovery of live probiotic bacteria in the stool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are between 18-70 years of age. Have regular bowel movements. Are willing and able to attend study visits, undergo limited blood and urine testing, take the nutritional supplement according to the instructions provided.
- •Are willing to collect four stool specimens and bring them to the study site.
排除标准
- •Are unwilling to follow the dietary guidelines of the study. Are lactose-intolerant or have allergies to milk or wheat. Have had drug or alcohol problems within the previous year. Are or plan to become pregnant over the next 3 months.
研究组 & 干预措施
Probiotic group
干预措施: ProNutrients Probiotic (Dietary Supplement)
Control group
This is a non-supplemented control group that will follow the same dietary and medication restrictions. The purpose of this group is to ensure results are due to supplementation and not due to random dietary exposure.
结局指标
主要结局
Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 3 weeks
时间窗: Baseline, 3 weeks
Pre- to post-supplementation changes in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR
次要结局
- Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR at baseline and 2 weeks(Baseline, 2 weeks)
- Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 3 weeks(Baseline, 3 weeks)
- Change in fecal concentration of both LGG and BB-12 by quantitative PCR (qPCR) at baseline and 2 weeks(Baseline, 2 weeks)
- Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group at baseline and 3 weeks(Baseline, 3 weeks)
- Change in fecal concentration of both LGG and BB-12 by quantitative culture with confirmatory PCR and qPCR in probiotic compared to control group at baseline and 2 weeks(Baseline, 2 weeks)
- Change in fecal concentration of LGG and BB-12 by both quantitative culture with confirmatory PCR and qPCR at baseline, 3 weeks, and 28 days post supplementation(Baseline, 3 weeks, 28 days follow up)