The Impact of Chronic Consumption of Prebiotics on Cognitive and Affective Outcomes, Gut Microbiome Diversity and Composition in 3-5 Year Olds: a Double-blind Placebo-controlled, Parallel-groups Randomised Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Child Behaviour Checklist Ages 1.5-5
概览
简要总结
This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.
详细描述
This study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 8-week-long prebiotic consumption on cognitive, behavioural, and gut microbiome, outcomes in 3-5-year-old children with insufficient fibre intake (less than the average 10.4g/day in 18-47-month-olds and less than 12.6g/day in 48-60-month-olds). One hundred and six participants will be randomised to Intervention or Placebo groups where they will be consuming 5g of prebiotic fibre or 5g of placebo (matched placebo powder) per day for 8-weeks. Outcome measures will be acquired before and after a 8-week chronic supplementation. These will include cognitive and behavioural outcomes of the parents and children. In addition, stool samples will be collected at the baseline and at week 8 to assess microbiome diversity and composition. Additionally, after 4-weeks of wash-out, at 12 weeks, parents will be asked to completed online questionnaires assessing cognitive and behavioural outcome of their children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents (18 years and over) of generally healthy children aged 3-5-years-old (36-71 months) with lower dietary fibre intake than the recommended daily amount (10.4g/day in 18-47-month-olds and less than 12.6g/day in 48-60-month-olds).
排除标准
- •Children with a significant acute or chronic co-existing illness (including inflammatory bowel disease, functional gastrointestinal disorders, coeliac disease etc, neurodevelopmental, immunological, psychiatric, or metabolic disorders.
- •Children who have taken any pre/probiotic supplements or antibiotic treatment within the 4 weeks prior to enrolment.
- •Children with food allergies and intolerances
研究组 & 干预措施
Prebiotic (powder)
Children will consume two (one in the morning and one in the evening) 2.5g of prebiotic sachets a day (mixed with food and drink).
干预措施: Prebiotic powder (Dietary Supplement)
Matched placebo (powder)
Children will consume two (one in the morning and one in the evening) 2.5g of placebo sachets a day (mixed with food and drink).
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Child Behaviour Checklist Ages 1.5-5
时间窗: This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)
Parents will be asked to complete this validated measure that includes 100 items that assesses a child's emotional, behavioral, and social problems.
次要结局
- Emotion Regulation Skills Questionnaire(This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out))
- Childhood Autism Spectrum Test(This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out))
- Bristol Stool Chart(This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out))
- Gut microbiome diversity(This measure will be taken at baseline (pre intervention) and week 8 (post intervention).)
- Gut microbiome composition(This measure will be taken at baseline (pre intervention) and week 8 (post intervention).)
研究者
Piril Hepsomali
Principle Investigator
University of Reading