The Feasibility of a Microbiome Dietary Intervention in Children With ADHD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ADHD
- Sponsor
- St Mary's University College
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Completion of study
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Completion of study
Time Frame: final week
What proportion of participants completed the study?
Secondary Outcomes
- 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)