The Feasibility of a Dietary Intervention in Children With ADHD

The Feasibility of a Microbiome Dietary Intervention in Children With ADHD

The aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.

Study Overview

• Status: Unknown
• Conditions: Diet Modification; ADHD
• Intervention / Treatment: Other: Diet modification

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, TW14SX
    • St Mary's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diet modification

Other: Diet modification; 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: Eat at least seven portions of different varieties of fruit and vegetables each day.; Have a 12 hour overnight break from food (water only during this time).; Drink a Kefir drink each day - provided free of charge.; Eat a microbiome friendly, protein rich, breakfast from our menu.; Reduce sugar and artificial sweeteners.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of study	What proportion of participants completed the study?	final week

Secondary Outcome Measures

Outcome Measure	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	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); Disruptive Behavior Indicator; Learning and Language Disorder Indicator; Mood Disorder Indicator; Anxiety Disorder Indicator; ADHD Indicator	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); Disruptive Behavior Indicator; Learning and Language Disorder Indicator; Mood Disorder Indicator; Anxiety Disorder Indicator; ADHD Indicator	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); Disruptive Behavior Indicator; Learning and Language Disorder Indicator; Mood Disorder Indicator; Anxiety Disorder Indicator; ADHD Indicator	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; DMS Percent Correct (overall, for all delays, simultaneous, 0 sec delay, 4 sec delay, 12 sec delay). Range 0-100% - higher score reflects greater accuracy.; DMS Mean & Median Correct Latency (overall, for all delays, simultaneous, 0 sec delay, 4 sec delay, 12 sec delay). Range 0-∞ ms - higher score reflects worse performance.; DMS Correct Latency Standard Deviation. Range 0-∞ ms - higher score reflects worse performance.; DMS Mean Choices to Correct response. Range 0-4 - higher score reflects worse performance.; DMS Probability of Error Given Error. Range 0-1 - higher score reflects worse performance.	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; Mean activity during sleep. Range 0-∞. A higher score = less sound sleep (worse).; Minutes spent awake during the down period. Range 0-∞. A higher score = less sound sleep (worse).; Sleep latency (time taken to fall asleep). Range 0-∞. A higher score = more time taken to fall asleep (worse).; Sleep efficiency (% down period spent asleep, after removing sleep latency). A higher score = better.; Wake after sleep onset (minutes spent awake during the down period after removing sleep latency). Range 0-∞. A higher score = less sound sleep (worse).; Sleep fragmentation (number of awakenings/ total minutes of sleep x 100) - Higher score = more fragmented sleep (worse).; Mean daytime activity (0-∞) not necessarily worse or better.	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: Abdominal pain (abdominal pain, hunger pains and nausea). Range 3-21 - a high score reflects worse symptoms.; Reflux syndrome (heartburn and acid regurgitation). Range 3-21 - a high score reflects worse symptoms.; Diarrhoea syndrome (diarrhoea, loose stools and urgent need for defecation). Range 3-21 - a high score reflects worse symptoms.; Indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus). Range 3-21 - a high score reflects worse symptoms. Range 3-21 - a high score reflects worse symptoms.; Constipation syndrome (constipation, hard stools and feeling of incomplete evacuation). Range 3-21 - a high score reflects worse symptoms.	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

Collaborators and Investigators

• Sponsor: St Mary's University College
• Collaborators: Goldsmiths, University of London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: ADHD; Diet Modification
• Other Study ID Numbers: SMEC_2017-18_132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At the request of individual researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No