Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Microbiota composition
研究概览
简要总结
Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea because of their ability to stimulate beneficial bacteria. In-vitro results showed a promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota. As the microbiota is nowadays considered as a key factor in human health, a further understanding of the gut microbiota functioning in-vivo is essential. This understanding of the use of specific prebiotics may possibly be beneficial in the prevention or recovery of antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota composition and activity from healthy adults receiving amoxicillin have never been tested in-vivo, the investigators propose the current study as a proof of principle.
Objective:
To explore whether the promising effects of GOS supplementation on the composition and activity of gut microbiota from healthy adults as found by in-vitro, can also be observed in-vivo.
Study population:
10 healthy men and women volunteers, 18 - 40 yr old
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-40 *
- •BMI: 18.5-25 kg/m2
- •Stable weight over the last 6 months
- •Western diet
- •Availability of information about birth by caesarean section and breast-feeding
- •Regular defecation (~1day)
- •Healthy as judge by the participant himself
- •Having signed the informed consent form
排除标准
- •Smoking or drug use
- •Pregnant (include planning to be or gave birth in the last 6 months) or lactating woman
- •Using contraceptive pill
- •Gastro-intestinal diseases (e.g. irritable bowel syndrome, inflammatory bowel disease)
- •Traveling to an Asian, African or south American country < 6 months before the study
- •Hypersensitivity or food allergy for products used in this study (e.g. Lactose, Penicillin)
- •Having hepatic disease and renal failure
- •Using medication other than paracetamol, acetylsalicylic acid (aspirin), hay fever, asthma
- •Not willing to have the family doctor be informed about participation to the study.
- •Antibiotic use < 3 months before the study
- •More than 3 antibiotic treatments in the last 2 years.
- •Probiotic or prebiotic use < 1 month before the study*
研究组 & 干预措施
GOS addition
All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 1 receives a drink with GOS (2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner.
干预措施: GOS addition (Dietary Supplement)
GOS addition
All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 1 receives a drink with GOS (2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner.
干预措施: Placebo (Dietary Supplement)
placebo (maltodextrine)
All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 2 receives a drink with placebo, maltodextrin(2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner.
干预措施: GOS addition (Dietary Supplement)
placebo (maltodextrine)
All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 2 receives a drink with placebo, maltodextrin(2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Microbiota composition
时间窗: evaluation between july and september 2013
Microbiota composition of the collected faecal sample will be investigated using a phylogenetic microarray, the Intestinal-Chip. With this microarray, more than 400 species of the intestinal microbiota can be detected. Bifidobacteria and Lactobacillus as beneficial bacteria as well as Enterobacteriaceae and possible other pathogens (Cells/ g faecal dry weight) will also be measured using a real-time PCR with specific primers.
次要结局
- Microbiota activity(evaluation between july and september 2013)