ADHD
Conditions
Keywords
microbiome, ADHD, probiotic, Kefir
Brief summary
This randomised, placebo controlled trial explores the effects of supplementation with a probiotic drink (kefir) in children diagnosed with ADHD on behaviour, sleep, attention and the gut microbiome.
Detailed description
Children with Attention Deficit Hyperactivity Disorder (ADHD) can suffer debilitating symptoms, including problematic behaviour and sleep. Dietary manipulations may be a helpful treatment option for children, but the most effective are highly restrictive, with little known about why they might work. Optimising gut bacteria may help alleviate some of the symptoms of this condition via the gut-brain-axis. The consumption of a probiotic fermented drink (kefir) can positively influence composition of gut bacteria. The purpose of this study is to explore the effects of supplementation of a probiotic drink (kefir) on behaviour, sleep, attention and the gut microbiome in children diagnosed with ADHD. In a six-week randomised controlled double-blind, placebo controlled trial, 70 children diagnosed with ADHD (aged 8-13 years) will be randomised to be given either a probiotic drink (kefir) or a placebo drink. At the beginning and the end of the study a combination of questionnaires, cognitive assessment, sleep/physical activity measures and microbiome analysis will be employed to assess the effect of kefir consumption on symptoms of ADHD and the gut microbiome.
Interventions
DIETARY_SUPPLEMENTExperimental: Kefir probiotic drink (supplied by Nourish)
125ml per day of dairy based probiotic drink (Kefir) containing ≥ 50billion colony forming units (CFU), supplied in plain packaging.
DIETARY_SUPPLEMENTPlacebo comparator
125ml of non-fermented dairy based placebo (UHT milk) per day, supplied in plain packaging.
Sponsors
Goldsmiths, University of London
London South Bank University
St. Mary's University, Twickenham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
a randomly generated 6-digit participant code will be allocated to each participant as a unique identifier for all data collection.
Intervention model description
Randomised double-blind quantitative repeated measures design
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* A previous diagnosis of ADHD according to the DSM-IV or DSM-V criteria by a qualified health care professional. * Children aged between 8 and 13 years at the time of study. * Children with a comorbidity will be accepted. * Both males and females
Exclusion criteria
* Children currently undergoing a current course of behavioural therapy. * Children with a reported milk allergy or lactose intolerance. * Reported use of antibiotics, probiotics, antifungals or steroids in the past four weeks. * Diagnosis of a gastrointestinal disorder e.g., Inflammatory Bowel Disease or Coeliac disease. * Diagnosis of an auto-immune disease or compromised immunity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in The Strengths and Weakness of ADHD-symptoms and Normal-behaviour (SWAN) scale | week 0 and week 6 | 18 item scale comparing the child to other children of the same age. Each item is responded to on a seven-point scale ranging from far below average (-3) to far above average (+3). The scores are summed and divided by the number of items, to express the summary score as the average rating-per-item (range -3 to +3, with lower scores indicating more severe ADHD symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean activity during sleep. | week 0 and week 6 | Actigraphy recordings. Range 0-∞. A higher score = less sound sleep (worse). |
| Change in minutes spent awake during the down period | week 0 and week 6 | Actigraphy recordings. Range 0-∞. A higher score = less sound sleep (worse). |
| Change in sleep latency | week 0 and week 6 | Actigraphy recordings of time taken to fall asleep. Range 0-∞. A higher score = more time taken to fall asleep (worse). |
| Change in sleep efficiency | week 0 and week 6 | Actigraphy recordings of % down period spent asleep, after removing sleep latency. A higher score = better. |
| Change in wake after sleep onset | week 0 and week 6 | Actigraphy recordings of minutes spent awake during the down period after removing sleep latency. Range 0-∞. A higher score = less sound sleep (worse). |
| Change in sleep fragmentation | week 0 and week 6 | Actigraphy recordings of the number of awakenings/ total minutes of sleep x 100) - Higher score = more fragmented sleep (worse). |
| Change in The Go/NoGo test | week 0 and week 6 | Participants respond to a particular stimulus while various stimuli are presented on a computer screen. There are 1500 milliseconds between each response, with 320 repetitions. Go errors (errors of omission) - A higher score = greater inattention (worse) NoGo errors (errors of commission) - A higher score = greater impulsivity (worse) Go reaction times - A higher score = less impulsivity (better) Go reaction time variability - A higher score = greater inattention (worse) |
| The Consensus Sleep diary | week 0 and week 6 | Record of sleep - used qualitatively to detect and remove artefacts from the data. Takes approximately 3 minutes per day to complete. |
| Change in The Child's Sleep habits questionnaire | week 0 and week 6 | Consists of 33 items. Each item is rated by parents using a three-point scale (with some items reverse-scored): 3 - Usually =occurs 5+ times a week 2 - Sometimes = occurs 2-4 times a week 1 - Rarely = occurs 0-1 times a week A Total Sleep Disturbances score is calculated as the sum of all scored questions. Total scores range from 33 to 99 - higher scores indicate more problematic sleep. |
| Change in Sleep self report | week 0 and week 6 | Consists of 26 items. Each item is rated by children using a three-point scale (with some items reverse-scored): 3 - Usually = occurs 5+ times a week 2 - Sometimes = occurs 2-4 times a week 1 - Rarely = occurs 0-1 times a week. A Total Sleep Disturbances score is calculated as the sum of all scored questions. Total scores range from 26 to 78 - higher scores indicate more problematic sleep. |
| Change in The Gastrointestinal Severity Index | week 0 and week 6 | A three-point rating scale across six gastrointestinal symptoms. A higher scores indicate worse symptoms. Total scores range from 0-12 - higher scores indicating more severe symptoms. |
| Change in stool microbiome analysis | week 0 and week 6 | Investigate if there are changes in diversity and species in week 6 relative to week 0. |
| Change in mean daytime activity | week 0 and week 6 | Actigraphy recording of mean daytime activity. (0-∞) not necessarily worse or better. |
Countries
United Kingdom
Outcome results
None listed