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| Name | Class |
|---|---|
| Goldsmiths, University of London | OTHER |
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The aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet modification | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet modification | Other | The parents will have four group sessions with a nutritional therapist, where in depth advice and information about the diet will be provided. Ongoing support will also be provided throughout the study by use of a closed Facebook or WhatsApp group (whichever the parents choose as most appropriate). The diet is based on five main principles:
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| Measure | Description | Time Frame |
|---|---|---|
| Completion of study | What proportion of participants completed the study? | final week |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to diet | Percentage adherence to diet over the 4-week period based on parental report (range 0-100 % - high score reflecting greater degree of adherence). | week 6 of diet |
| Side-effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mary's University | London | TW14SX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35606889 | Derived | 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. |
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At the request of individual researchers.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2025 | |
| Reset | Jun 2, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2025 | Jun 2, 2025 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome).
| duration of the 6 week diet |
| The Conners Clinical Index (Conners CI) - Parent-report | Parental report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms)
| Baseline and week 6 of diet |
| The Conners Clinical Index (Conners CI) - Teacher-report | Teacher report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms)
| Baseline and week 6 of diet |
| The Conners Clinical Index (Conners CI) - Self-report | Child self-report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms)
| Baseline and week 6 of diet |
| Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected). | Computerised test of visual working memory
| Baseline and week 6 of diet |
| The Consensus Sleep Diary | Record of sleep - used qualitatively to detect and remove artefacts from the data. | Baseline and week 6 of diet |
| Children's Sleep Habits Questionnaire | Parental report of child's sleep A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99. A higher score indicates more problematic sleep. | Baseline and week 6 of diet |
| Sleep self-report questionnaire | Week long retrospective sleep survey (Scores range from 13-39 with a higher score indicating more/more severe sleep difficulties). | Baseline and week 6 of diet |
| Actigraphy recordings | Objective measure of sleep quality and daytime activity
| Baseline and week 6 of diet |
| The Gastrointestinal Symptom Rating | Questionnaire to evaluate common gastrointestinal symptoms Total scores range from 15-105 (with higher scores reflecting more/more severe gastrointestinal symptoms). Subscales:
| Baseline and week 6 of diet |
| Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing | Analysis of bacterial strains and diversity within stool sample | Baseline and week 6 of diet |
| Treatment Acceptability Scale | Questionnaire to assess the acceptability of the diet to parents of the children taking part in the study Score range 6-42 (High score reflects more positive attitude to treatment) | Baseline and week 6 of diet |