Clinical trial NCT03737877: The Feasibility of a Dietary Intervention in Children With ADHD
Official title: The Feasibility of a Microbiome Dietary Intervention in Children With ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Diet Modification
Keywords: ADHD
Diet Modification
Lead sponsor: St Mary's University College
Sponsor class: OTHER
Collaborators: name: Goldsmiths, University of London
First posted: 2018-11-13
Enrollment: 9
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Parent-reported diagnosis of ADHD.
2. Children aged between 8 years - 13 years 11 months at onset of study.
3. Children not taking ADHD medication (such as methylphenidate) at the time of the study.
4. Parental permission to attend three group sessions and for themselves and their child to complete the requisite assessments.
5. Both males and females are eligible to take part.
6. Children with a co-occurring diagnosis will be accepted onto the trial.
7. Children with food allergies/sensitivities/coeliac disease will be accepted onto the trial.

Exclusion Criteria:

1. Children undergoing a current course of behavioural therapy.
2. Children currently on ADHD medication (such as methylphenidate).
3. Children who have taken antibiotics in the past 3 months

Primary outcomes:
measure: Completion of study
timeFrame: final week
Secondary outcomes:
measure: Adherence to diet
timeFrame: week 6 of diet
measure: Side-effects
timeFrame: duration of the 6 week diet
measure: The Conners Clinical Index (Conners CI) - Parent-report
timeFrame: Baseline and week 6 of diet
measure: The Conners Clinical Index (Conners CI) - Teacher-report
timeFrame: Baseline and week 6 of diet
measure: The Conners Clinical Index (Conners CI) - Self-report
timeFrame: Baseline and week 6 of diet
measure: Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected).
timeFrame: Baseline and week 6 of diet
measure: The Consensus Sleep Diary
timeFrame: Baseline and week 6 of diet
measure: Children's Sleep Habits Questionnaire
timeFrame: Baseline and week 6 of diet
measure: Sleep self-report questionnaire
timeFrame: Baseline and week 6 of diet
measure: Actigraphy recordings
timeFrame: Baseline and week 6 of diet
measure: The Gastrointestinal Symptom Rating
timeFrame: Baseline and week 6 of diet
measure: Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing
timeFrame: Baseline and week 6 of diet
measure: Treatment Acceptability Scale
timeFrame: Baseline and week 6 of diet
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's University
Study officials:
References:
citation: Lawrence K, Myrissa K, Toribio-Mateas M, Minini L, Gregory AM. Trialling a microbiome-targeted dietary intervention in children with ADHD-the rationale and a non-randomised feasibility study. Pilot Feasibility Stud. 2022 May 23;8(1):108. doi: 10.1186/s40814-022-01058-4.