Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
81 participants
INTERVENTIONAL
2022-01-06
2023-09-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Probiotics on Children With ADHD
NCT06348121
Nutritional Intervention for Children With ASD and/or ADHD
NCT05167110
Effects of a Probiotic Supplement on Symptoms of Attention Deficit Hyperactivity Disorder and Anxiety in Children
NCT02545634
Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder
NCT04167995
Treating Impulsivity in Adults With Probiotics
NCT03495375
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Kefir probiotic drink
Daily kefir for 6 weeks.
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.
placebo comparator
Daily non-fermented dairy based equivalent drink for 6 weeks.
Placebo comparator
125ml of non-fermented dairy based placebo (UHT milk) per day, supplied in plain packaging.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Placebo comparator
125ml of non-fermented dairy based placebo (UHT milk) per day, supplied in plain packaging.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
8 Years
13 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Goldsmiths, University of London
OTHER
London South Bank University
OTHER
St. Mary's University, Twickenham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kate
Senior Lecturer in Psychology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kate Lawrence, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Mary's University, Twickenham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Mary's University
London, Greater London, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lawrence 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMU_ETHICS_2020-21_240
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.