Randomized Controlled Trial on Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Relative abundance of Bifidobacterium in the gut
研究概览
简要总结
Human Milk Oligosaccharides (HMOs) are the third most abundant class of nutrients in human milk. Studies investigating the effects of dietary HMOs in infants have shown various health and developmental benefits such as the development of the early gut microbiome (by favouring colonisation of beneficial Bifidobacterium, Lactobacillus, and Bacteroides), the development of the immune system, general infant growth, protection against infectious diseases and allergies, and stimulation of cognitive development. Only a limited number of studies have been conducted in adults, showing intake of HMOs stimulates the growth of gut Bifidobacterium in healthy adults.
详细描述
The current study aims to investigate the effects of a 4-week intervention with two HMOs on gut microbiome composition, immune function and gastrointestinal symptoms in healthy adults with mild to moderate gastrointestinal complaints. The study will be conducted as a partially decentralized, double-blind, randomized, placebo-controlled, parallel group design.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 40 and ≤ 55 years
- •Male/female
- •Total score of >2 on the Gastrointestinal Symptom Rating Scale (GSRS)
- •Body Mass Index 18-30 kg/m2
- •Stable body weight (± 5%) for at least 6 months
- •Stable lifestyle and dietary habits within the 4 weeks prior and during study period
- •Owns device (computer, smartphone, tablet) with access to the internet
- •Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
- •Sufficient vision and hearing to complete study procedures
- •Willing and able to participate, follow the study procedures and to give written informed consent
排除标准
- •History (< 6 months prior to the study) or presence of severe gastrointestinal, metabolic, immunological, psychiatric disorder, or major surgery
- •Current or past (< 4 weeks) use of prescription, over-the-counter, or traditional medication, or dietary supplements with a relevant impact on GI system or on visceral motility
- •Having received antibiotic treatment < 4 weeks prior to study
- •Alcohol intake >1 units/day
- •Currently pregnant or pregnancy in past 6 months
- •Use of pro/prebiotics < 4 weeks prior to study start
- •Fully vegetarian/vegan diet < 4 weeks prior to study start
- •High habitual vegetable and fruit intake (> 2 servings of fruits and >2 servings of vegetables per day) < 4 weeks prior to study start
- •Lactose intolerance
- •Maltodextrin allergy
- •Members of the research team or their immediate family members. Immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted
研究组 & 干预措施
HMO 1
干预措施: HMO 1 (Dietary Supplement)
HMO 2
干预措施: HMO 2 (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Relative abundance of Bifidobacterium in the gut
时间窗: 4 weeks
次要结局
- Gut microbiome functional potential (functional metagenomics analyses)(4 weeks)
- Relative abundance of other bacterial taxa in the gut(4 weeks)
- Stool Human Milk Oligossacharides level(4 weeks)
- Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel)(4 weeks)