An interventional study of Experimental: Kefir probiotic drink (supplied by Nourish) and Placebo comparator in ADHD, sponsored by St. Mary's University, Twickenham. Completed at 1 site in United Kingdom. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by St. Mary's University, Twickenham · Not applicable, Interventional, and Treatment
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.
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 81 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →St. Mary's University, Twickenham is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily kefir for 6 weeks.
Dietary Supplement: Experimental: Kefir probiotic drink (supplied by Nourish)
Daily non-fermented dairy based equivalent drink for 6 weeks.
Dietary Supplement: Placebo comparator
125ml per day of dairy based probiotic drink (Kefir) containing ≥ 50billion colony forming units (CFU), supplied in plain packaging.
125ml of non-fermented dairy based placebo (UHT milk) per day, supplied in plain packaging.
Change in The Strengths and Weakness of ADHD-symptoms and Normal-behaviour (SWAN) scale
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).
Time frame: week 0 and week 6
Change in The Go/NoGo test
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)
Time frame: week 0 and week 6
Change in mean activity during sleep.
Actigraphy recordings. Range 0-∞. A higher score = less sound sleep (worse).
Time frame: week 0 and week 6
Change in minutes spent awake during the down period
Actigraphy recordings. Range 0-∞. A higher score = less sound sleep (worse).
Time frame: week 0 and week 6
Change in sleep latency
Actigraphy recordings of time taken to fall asleep. Range 0-∞. A higher score = more time taken to fall asleep (worse).
Time frame: week 0 and week 6
Change in sleep efficiency
Actigraphy recordings of % down period spent asleep, after removing sleep latency. A higher score = better.
Time frame: week 0 and week 6
Change in wake after sleep onset
Actigraphy recordings of minutes spent awake during the down period after removing sleep latency. Range 0-∞. A higher score = less sound sleep (worse).
Time frame: week 0 and week 6
Change in sleep fragmentation
Actigraphy recordings of the number of awakenings/ total minutes of sleep x 100) - Higher score = more fragmented sleep (worse).
Time frame: week 0 and week 6
Change in mean daytime activity
Actigraphy recording of mean daytime activity. (0-∞) not necessarily worse or better.
Time frame: week 0 and week 6
The Consensus Sleep diary
Record of sleep - used qualitatively to detect and remove artefacts from the data. Takes approximately 3 minutes per day to complete.
Time frame: week 0 and week 6
The Consensus Sleep diary
Record of sleep - used qualitatively to detect and remove artefacts from the data. Takes approximately 3 minutes per day to complete.
Time frame: week 6
Change in The Child's Sleep habits questionnaire
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.
Time frame: week 0 and week 6
Change in Sleep self report
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.
Time frame: week 0 and week 6
Change in The Gastrointestinal Severity Index
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.
Time frame: week 0 and week 6
Change in stool microbiome analysis
Investigate if there are changes in diversity and species in week 6 relative to week 0.
Time frame: week 0 and week 6
Plan to share: Yes — anonymised data will be made available on an open access repository.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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St. Mary's University, Twickenham