ADHDNCT03737877
The Feasibility of a Dietary Intervention in Children With ADHD
A study testing Diet modification in people with ADHD and Diet Modification, run by St Mary's University College at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- ADHD, Diet Modification
- What is being tested?
- Diet modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 May 2019to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ADHD, Diet Modification
- Being tested
- Diet modification
- Keywords
- ADHD, Diet Modification
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet modificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet modification | Experimental | Not described Receives: Other: Diet modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of study
What proportion of participants completed the study?
Measured: final week
Secondary outcomes (13)
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).
Measured: week 6 of diet
Side-effects
Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline and week 6 of diet
The Consensus Sleep Diary
Record of sleep - used qualitatively to detect and remove artefacts from the data.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Baseline and week 6 of diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start14 May 2019
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Collaborators
- Goldsmiths, University of London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737877
- Sponsor's protocol ID
- SMEC_2017-18_132
- Status last verified
- Jun 2019
- First submitted
- 8 Nov 2018
- Last updated
- 6 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the request of individual researchers.
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.
PubMed 35606889
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Microbiome Dietary Intervention in Children With ADHD
- ClinicalTrials.gov ID
- NCT03737877
- Acronym / sponsor ID
- SMEC_2017-18_132
- Conditions
- ADHD, Diet Modification
- Keywords
- ADHD, Diet Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Collaborators
- Goldsmiths, University of London
- Study start
- 14 May 2019 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet modification | Experimental | Other: Diet modification |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet modificationThe 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. | Other | Diet modification |
Primary outcome
Completion of study
Time frame: final week
What proportion of participants completed the study?
13 secondary outcomes
Adherence to diet
Time frame: week 6 of diet
Side-effects
Time frame: duration of the 6 week diet
The Conners Clinical Index (Conners CI) - Parent-report
Time frame: Baseline and week 6 of diet
The Conners Clinical Index (Conners CI) - Teacher-report
Time frame: Baseline and week 6 of diet
The Conners Clinical Index (Conners CI) - Self-report
Time frame: Baseline and week 6 of diet
Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected).
Time frame: Baseline and week 6 of diet
The Consensus Sleep Diary
Time frame: Baseline and week 6 of diet
Children's Sleep Habits Questionnaire
Time frame: Baseline and week 6 of diet
Sleep self-report questionnaire
Time frame: Baseline and week 6 of diet
Actigraphy recordings
Time frame: Baseline and week 6 of diet
The Gastrointestinal Symptom Rating
Time frame: Baseline and week 6 of diet
Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing
Time frame: Baseline and week 6 of diet
Treatment Acceptability Scale
Time frame: Baseline and week 6 of diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 35606889Lawrence 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.
- Individual participant dataSharing planned: Undecided. At the request of individual researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet modification in people with ADHD and Diet Modification, run by St Mary's University College at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of study (time frame: final week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.