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Completed

NCT Number: NCT05155696

Probiotic Supplementation in Children With ADHD

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Mary's University

London, Greater London, TW1 4SX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Kefir probiotic drink (supplied by Nourish)

Dietary Supplement

125ml per day of dairy based probiotic drink (Kefir) containing ≥ 50billion colony forming units (CFU), supplied in plain packaging.

Placebo Comparator

Dietary Supplement

125ml of non-fermented dairy based placebo (UHT milk) per day, supplied in plain packaging.

Primary outcomes

  1. Change in The Strengths and Weakness of ADHD-symptoms and Normal-behaviour (SWAN) scale

    Time frame: 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 outcomes

  1. Change in The Go/NoGo test

    Time frame: 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)

  2. Change in mean activity during sleep.

    Time frame: week 0 and week 6

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

  3. Change in minutes spent awake during the down period

    Time frame: week 0 and week 6

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

  4. Change in sleep latency

    Time frame: 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).

  5. Change in sleep efficiency

    Time frame: week 0 and week 6

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

  6. Change in wake after sleep onset

    Time frame: 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).

  7. Change in sleep fragmentation

    Time frame: week 0 and week 6

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

  8. Change in mean daytime activity

    Time frame: week 0 and week 6

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

  9. The Consensus Sleep diary

    Time frame: 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.

  10. The Consensus Sleep diary

    Time frame: week 6

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

  11. Change in The Child's Sleep habits questionnaire

    Time frame: 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.

  12. Change in Sleep self report

    Time frame: 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.

  13. Change in The Gastrointestinal Severity Index

    Time frame: 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.

  14. Change in stool microbiome analysis

    Time frame: week 0 and week 6

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

Sponsors and collaborators

Lead sponsor

St. Mary's University, Twickenham

Other

Collaborators

  • Goldsmiths, University of London
  • London South Bank University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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