Dietary Study of a Complex Oligosaccharide With and Without a Probiotic in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
研究概览
简要总结
Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.
详细描述
The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers. The combination should support general gastrointestinal health.
The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-44.
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
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between the ages of 18-44 years
- •Willingness to complete all study procedures and clinic visits, and provide required samples
- •Provides informed consent
排除标准
- •Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study
- •Subjects with history of lactose intolerance
- •Subjects who are on a PPI regimen
- •Subjects who have taken a probiotic during the previous 30 days, or intends to take a probiotic during the study.
- •Subjects who have taken antibiotics within 120 days
- •Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening
- •Unstable medical condition, in the opinion of the investigator
- •Clinically significant abnormal laboratory test results at screening
- •Participation in a clinical research trial within 30 days prior to screening
- •Unable to give informed consent
- •Any condition which may preclude subject's ability to comply with and complete the study or may pose a risk to the health of the subject
结局指标
主要结局
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
时间窗: All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57
qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species.
次要结局
- Changes in Concentration of Blood Parameters From Day 1 to Day 15(Day 1 - 15)
- Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit(Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57)
- Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29(Day 1, 8, 15, 29)
- Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)(Day 1 - 15)
- Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)(Day 1 - 15)