Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- increase in fecal butyrate concentration
研究概览
简要总结
This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week clinical trial on healthy volunteers. Following a two week run-in-period, subjects were randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a 3-week wash-out period before the second treatment period, followed by a another wash-out period. Volunteers completed questionnaires for each period on overall health and well being, stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to collect fecal samples for investigation of microbiological and microbial metabolites before and after three treatment periods. The primary objective of the study is tan increase in fecal butyrate concentration. Secondary objectives are changes in microbiota composition and short-chain fatty acids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy individuals between 18-50 years of age who had not used antibiotics three months prior to the trial
排除标准
- •chronic illness
- •regular intake of medication (except birth-control pills)
- •post-menopausal women
研究组 & 干预措施
Maltodextrin
'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day
干预措施: Combination of Lactobacillus acidophilus NCFM and cellobiose (Dietary Supplement)
Synbiotic
'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU
干预措施: Combination of Lactobacillus acidophilus NCFM and cellobiose (Dietary Supplement)
结局指标
主要结局
increase in fecal butyrate concentration
时间窗: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
次要结局
- changes in composition of microbiota(12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period))
- changes in short-chain fatty acids(12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period))
研究者
Gabriella C. van Zanten
PhD student
University of Copenhagen