The Feasibility of a Dietary Intervention in Children With ADHD

ADHD Clinical Trial

Official title:

The Feasibility of a Microbiome Dietary Intervention in Children With ADHD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03737877
• Other study ID #: SMEC_2017-18_132
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: July 2019

Study information

• Verified date: June 2019
• Source: St Mary's University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Diet Modification

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	St Mary's University	London

Sponsors (2)

Lead Sponsor	Collaborator
St Mary's University College	Goldsmiths, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of study	What proportion of participants completed the study?	final week
Secondary	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
Secondary	Side-effects	Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome).	duration of the 6 week diet
Secondary	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
Secondary	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
Secondary	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
Secondary	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 0-8 ms - higher score reflects worse performance.; DMS Correct Latency Standard Deviation. Range 0-8 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
Secondary	The Consensus Sleep Diary	Record of sleep - used qualitatively to detect and remove artefacts from the data.	Baseline and week 6 of diet
Secondary	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
Secondary	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
Secondary	Actigraphy recordings	Objective measure of sleep quality and daytime activity; Mean activity during sleep. Range 0-8. A higher score = less sound sleep (worse).; Minutes spent awake during the down period. Range 0-8. A higher score = less sound sleep (worse).; Sleep latency (time taken to fall asleep). Range 0-8. 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 0-8. 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 (0-8) not necessarily worse or better.	Baseline and week 6 of diet
Secondary	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
Secondary	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
Secondary	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