The Feasibility of a Microbiome Dietary Intervention in Children With ADHD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Completion of study
研究概览
简要总结
The aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.
详细描述
Children with Attention Deficit Hyperactivity Disorder (ADHD) can suffer debilitating symptoms, including problematic behaviour and sleep. Research suggests dietary manipulations may be a helpful treatment option for children with ADHD, although the most effective are highly restrictive, with little known about why they might work. Optimising gut bacteria in individuals with ADHD may help alleviate some of the symptoms of this condition via the gut-brain-axis and would provide a plausible mechanism by which dietary interventions operate. We propose to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent-reported diagnosis of ADHD.
- •Children aged between 8 years - 13 years 11 months at onset of study.
- •Children not taking ADHD medication (such as methylphenidate) at the time of the study.
- •Parental permission to attend three group sessions and for themselves and their child to complete the requisite assessments.
- •Both males and females are eligible to take part.
- •Children with a co-occurring diagnosis will be accepted onto the trial.
- •Children with food allergies/sensitivities/coeliac disease will be accepted onto the trial.
排除标准
- •Children undergoing a current course of behavioural therapy.
- •Children currently on ADHD medication (such as methylphenidate).
- •Children who have taken antibiotics in the past 3 months
研究组 & 干预措施
Diet modification
干预措施: Diet modification (Other)
结局指标
主要结局
Completion of study
时间窗: final week
What proportion of participants completed the study?
次要结局
- Adherence to diet(week 6 of diet)
- Side-effects(duration of the 6 week diet)
- The Conners Clinical Index (Conners CI) - Parent-report(Baseline and week 6 of diet)
- The Conners Clinical Index (Conners CI) - Teacher-report(Baseline and week 6 of diet)
- The Consensus Sleep Diary(Baseline and week 6 of diet)
- Children's Sleep Habits Questionnaire(Baseline and week 6 of diet)
- Sleep self-report questionnaire(Baseline and week 6 of diet)
- Actigraphy recordings(Baseline and week 6 of diet)
- The Gastrointestinal Symptom Rating(Baseline and week 6 of diet)
- Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing(Baseline and week 6 of diet)
- The Conners Clinical Index (Conners CI) - Self-report(Baseline and week 6 of diet)
- Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected).(Baseline and week 6 of diet)
- Treatment Acceptability Scale(Baseline and week 6 of diet)