Evaluation of the Effect of Different Nutrients on the Gut Microbiota Composition and Metabolic Activity by Using in Vitro Batch Fermentation and Cellular Models
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in microbiota composition
研究概览
简要总结
The correlation between diet and microbiota as well as the effect of microbiota on human health is well established. Studies have shown that people following specific diets have different microbiome profile compared to those following traditional or ordinary diets. In order to screen several food ingredients for their effects on human microbiota composition and metabolic activities, in vitro studies are proposed. Nutrients are added in-vitro in fecal sample, eliminating the need for participants to consume any nutritional product. The batch fermentation in vitro system simulates human colonic microbiota from fecal samples, enabling the complex mixture of microorganisms. This system could serve as a simple model to simulate the diversity as well as the metabolism of human colonic microbiota. We will evaluate the effect on nutrient/s on the age specific microbiome via an in vitro fermentation approach for the 0 to 60 year-old period.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participant aged from 0 to 60 (based on medical history, physical examination and review of childhood growth chart)
- •Written informed consent has been obtained from the parent(s)/legally acceptable representative (LAR) of toddlers and teenagers
- •Written informed consent has been obtained for participants aged from 14 years old and above
- •Child's parent(s)/legal representative or participant is willing and able to fulfill the requirements of the study protocol.
- •Ability to collect their or their infant/child's fecal sample.
排除标准
- •The parent(s)/legally acceptable representative (LAR) is not able to provide evidence of parental authority or legal representation.
- •Participant following a particular regimen of any type such as vegan, vegetarian, ketogenic, paleo diet,
- •Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily,
- •Antibacterial/antifungal therapy during the 3 months prior to study enrolment,
- •Medications or supplements that are known to alter gut function or microbiota (i.e. acid antisecretory drugs, pre-/probiotics supplements, laxatives) during the 4 weeks prior to study enrolment,
- •Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy),
- •Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer,
- •Artificially sweetened beverage intake higher than 1000 ml/ per day,
- •Current or history of gastrointestinal diseases like (Celiac Disease, Crohn's Disease, Ulcerative colitis, Irritable Bowel Syndrome, infantile colic, recurrent abdominal pain, functional constipation, ulcers, infections (based on anamnesis),
- •Participants participating in another interventional study,
- •Participants/parents having a hierarchical or family link with the research team members.
结局指标
主要结局
Change in microbiota composition
时间窗: Through study completion, an average of 1 year
Measured by 16s rRNA sequencing or next Generation Sequencing (NGS) or by qPCR
次要结局
- Change in metabolic profile(Through study completion, an average of 1 year)
- Change in Short Chain Fatty Acids (SCFA)(Through study completion, an average of 1 year)
- Protein expression of epithelial cells(Through study completion, an average of 1 year)