A Randomised Controlled Trial of the Effects of a Probiotic Drink on Behaviour, Sleep and the Microbiome in Children With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Change in The Strengths and Weakness of ADHD-symptoms and Normal-behaviour (SWAN) scale
研究概览
简要总结
This randomised, placebo controlled trial explores the effects of supplementation with a probiotic drink (kefir) in children diagnosed with ADHD on behaviour, sleep, attention and the gut microbiome.
详细描述
Children with Attention Deficit Hyperactivity Disorder (ADHD) can suffer debilitating symptoms, including problematic behaviour and sleep. Dietary manipulations may be a helpful treatment option for children, but the most effective are highly restrictive, with little known about why they might work.
Optimising gut bacteria may help alleviate some of the symptoms of this condition via the gut-brain-axis. The consumption of a probiotic fermented drink (kefir) can positively influence composition of gut bacteria.
The purpose of this study is to explore the effects of supplementation of a probiotic drink (kefir) on behaviour, sleep, attention and the gut microbiome in children diagnosed with ADHD.
In a six-week randomised controlled double-blind, placebo controlled trial, 70 children diagnosed with ADHD (aged 8-13 years) will be randomised to be given either a probiotic drink (kefir) or a placebo drink. At the beginning and the end of the study a combination of questionnaires, cognitive assessment, sleep/physical activity measures and microbiome analysis will be employed to assess the effect of kefir consumption on symptoms of ADHD and the gut microbiome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
a randomly generated 6-digit participant code will be allocated to each participant as a unique identifier for all data collection.
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A previous diagnosis of ADHD according to the DSM-IV or DSM-V criteria by a qualified health care professional.
- •Children aged between 8 and 13 years at the time of study.
- •Children with a comorbidity will be accepted.
- •Both males and females
排除标准
- •Children currently undergoing a current course of behavioural therapy.
- •Children with a reported milk allergy or lactose intolerance.
- •Reported use of antibiotics, probiotics, antifungals or steroids in the past four weeks.
- •Diagnosis of a gastrointestinal disorder e.g., Inflammatory Bowel Disease or Coeliac disease.
- •Diagnosis of an auto-immune disease or compromised immunity.
结局指标
主要结局
Change in The Strengths and Weakness of ADHD-symptoms and Normal-behaviour (SWAN) scale
时间窗: week 0 and week 6
18 item scale comparing the child to other children of the same age. Each item is responded to on a seven-point scale ranging from far below average (-3) to far above average (+3). The scores are summed and divided by the number of items, to express the summary score as the average rating-per-item (range -3 to +3, with lower scores indicating more severe ADHD symptoms).
次要结局
- Change in minutes spent awake during the down period(week 0 and week 6)
- Change in wake after sleep onset(week 0 and week 6)
- Change in mean daytime activity(week 0 and week 6)
- Change in The Gastrointestinal Severity Index(week 0 and week 6)
- Change in sleep latency(week 0 and week 6)
- Change in sleep efficiency(week 0 and week 6)
- Change in The Go/NoGo test(week 0 and week 6)
- Change in mean activity during sleep.(week 0 and week 6)
- Change in sleep fragmentation(week 0 and week 6)
- The Consensus Sleep diary(week 6)
- Change in The Child's Sleep habits questionnaire(week 0 and week 6)
- Change in Sleep self report(week 0 and week 6)
- Change in stool microbiome analysis(week 0 and week 6)
研究者
Kate
Senior Lecturer in Psychology
St. Mary's University, Twickenham