ADHDNCT05155696
Probiotic Supplementation in Children With ADHD
A study testing Experimental: Kefir probiotic drink (supplied by Nourish) in people with ADHD, run by St. Mary's University, Twickenham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Experimental: Kefir probiotic drink (supplied by Nourish)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2022to 26 Sep 2023
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Mary's University
London, Greater London, TW1 4SX
About this study
Official title: A Randomised Controlled Trial of the Effects of a Probiotic Drink on Behaviour, Sleep and the Microbiome 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.
Read the 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.
- Conditions
- ADHD
- Being tested
- Experimental: Kefir probiotic drink (supplied by Nourish), Placebo comparator
- Keywords
- microbiome, ADHD, probiotic, Kefir
- 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.
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 comparatorDietary supplement
125ml of non-fermented dairy based placebo (UHT milk) per day, supplied in plain packaging.
| Study group | Role | What they receive |
|---|---|---|
| Kefir probiotic drink | Experimental | Daily kefir for 6 weeks. Receives: Dietary Supplement: Experimental: Kefir probiotic drink (supplied by Nourish) |
| placebo comparator | Placebo comparator | Daily non-fermented dairy based equivalent drink for 6 weeks. Receives: Dietary Supplement: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: week 0 and week 6
Secondary outcomes (14)
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)
Measured: week 0 and week 6
Change in mean activity during sleep.
Actigraphy recordings. Range 0-∞. A higher score = less sound sleep (worse).
Measured: 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).
Measured: 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).
Measured: week 0 and week 6
Change in sleep efficiency
Actigraphy recordings of % down period spent asleep, after removing sleep latency. A higher score = better.
Measured: 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).
Measured: 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).
Measured: week 0 and week 6
Change in mean daytime activity
Actigraphy recording of mean daytime activity. (0-∞) not necessarily worse or better.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start6 Jan 2022
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised double-blind quantitative repeated measures design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Mary's University, Twickenham
- Sponsor type
- University, hospital or other
- Collaborators
- Goldsmiths, University of London, London South Bank University
- Responsible party
- Principal investigator, Kate, St. Mary's University, Twickenham
- Investigators
- Kate Lawrence, PhD, Principal investigator, St. Mary's University, Twickenham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155696
- Sponsor's protocol ID
- SMU_ETHICS_2020-21_240
- Status last verified
- Sep 2023
- First submitted
- 11 Nov 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymised data will be made available on an open access repository.
Publications
Lawrence K, Fibert P, Toribio-Mateas M, Gregory AM, Hobbs J, Quadt F, Wright S, Cotter PD, Patel S, Myrissa K. Effects of kefir on symptoms, sleep, and gut microbiota in children with ADHD: a randomised controlled trial. BMC Psychiatry. 2025 Nov 24;25(1):1117. doi: 10.1186/s12888-025-07568-8.
PubMed 41286799Lawrence K, Fibert P, Hobbs J, Myrissa K, Toribio-Mateas MA, Quadt F, Cotter PD, Gregory AM. Randomised controlled trial of the effects of kefir on behaviour, sleep and the microbiome in children with ADHD: a study protocol. BMJ Open. 2023 Dec 7;13(12):e071063. doi: 10.1136/bmjopen-2022-071063.
PubMed 38149413
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of the Effects of a Probiotic Drink on Behaviour, Sleep and the Microbiome in Children With ADHD
- ClinicalTrials.gov ID
- NCT05155696
- Acronym / sponsor ID
- SMU_ETHICS_2020-21_240
- Conditions
- ADHD
- Keywords
- microbiome, ADHD, probiotic, Kefir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- St. Mary's University, TwickenhamUniversity, hospital or other
- Collaborators
- Goldsmiths, University of London, London South Bank University
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 13 Dec 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised double-blind quantitative repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Kefir probiotic drink | Experimental | Dietary Supplement: Experimental: Kefir probiotic drink (supplied by Nourish)Daily kefir for 6 weeks. |
| placebo comparator | Placebo comparator | Dietary Supplement: Placebo comparatorDaily non-fermented dairy based equivalent drink for 6 weeks. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Experimental: 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 supplement | Kefir probiotic drink |
| Placebo comparator125ml of non-fermented dairy based placebo (UHT milk) per day, supplied in plain packaging. | Dietary supplement | placebo comparator |
Primary outcome
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).
14 secondary outcomes
Change in The Go/NoGo test
Time frame: week 0 and week 6
Change in mean activity during sleep.
Time frame: week 0 and week 6
Change in minutes spent awake during the down period
Time frame: week 0 and week 6
Change in sleep latency
Time frame: week 0 and week 6
Change in sleep efficiency
Time frame: week 0 and week 6
Change in wake after sleep onset
Time frame: week 0 and week 6
Change in sleep fragmentation
Time frame: week 0 and week 6
Change in mean daytime activity
Time frame: week 0 and week 6
The Consensus Sleep diary
Time frame: week 0 and week 6
The Consensus Sleep diary
Time frame: week 6
Change in The Child's Sleep habits questionnaire
Time frame: week 0 and week 6
Change in Sleep self report
Time frame: week 0 and week 6
Change in The Gastrointestinal Severity Index
Time frame: week 0 and week 6
Change in stool microbiome analysis
Time frame: week 0 and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 41286799Lawrence K, Fibert P, Toribio-Mateas M, Gregory AM, Hobbs J, Quadt F, Wright S, Cotter PD, Patel S, Myrissa K. Effects of kefir on symptoms, sleep, and gut microbiota in children with ADHD: a randomised controlled trial. BMC Psychiatry. 2025 Nov 24;25(1):1117. doi: 10.1186/s12888-025-07568-8.
- Derived from this study: PubMed 38149413Lawrence K, Fibert P, Hobbs J, Myrissa K, Toribio-Mateas MA, Quadt F, Cotter PD, Gregory AM. Randomised controlled trial of the effects of kefir on behaviour, sleep and the microbiome in children with ADHD: a study protocol. BMJ Open. 2023 Dec 7;13(12):e071063. doi: 10.1136/bmjopen-2022-071063.
- Individual participant dataSharing planned: Yes. anonymised data will be made available on an open access repository.
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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.
Kate Lawrence, PhD principal investigator
St. Mary's University, Twickenham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Kefir probiotic drink (supplied by Nourish) in people with ADHD, run by St. Mary's University, Twickenham 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 28 Sep 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in The Strengths and Weakness of ADHD-symptoms and Normal-behaviour (SWAN) scale (time frame: week 0 and week 6). 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 NCT05155696, which also lists 2 linked publications.
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 28 Sep 2023.