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.

Probiotic Supplementation in Children With ADHD

ADHD

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.

Experimental: Kefir probiotic drink (supplied by Nourish)

Placebo comparator

A Randomised Controlled Trial of the Effects of a Probiotic Drink on Behaviour, Sleep and the Microbiome in Children With ADHD

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).

Senior Lecturer in Psychology

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)

Actigraphy recordings. Range 0-∞. A higher score = less sound sleep (worse).

Actigraphy recordings of time taken to fall asleep. Range 0-∞. A higher score = more time
taken to fall asleep (worse).

Actigraphy recordings of % down period spent asleep, after removing sleep latency. A
higher score = better.

Actigraphy recordings of minutes spent awake during the down period after removing sleep
latency. Range 0-∞. A higher score = less sound sleep (worse).

Actigraphy recordings of the number of awakenings/ total minutes of sleep x 100) - Higher
score = more fragmented sleep (worse).

Actigraphy recording of mean daytime activity. (0-∞) not necessarily worse or better.

Record of sleep - used qualitatively to detect and remove artefacts from the data. Takes
approximately 3 minutes per day to complete.

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.

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.

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.

Investigate if there are changes in diversity and species in week 6 relative to week 0.

Daily non-fermented dairy based equivalent drink for 6 weeks.

Probiotic Supplementation in Children With ADHD

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status