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. 2023 Dec 7;13(12):e071063.
doi: 10.1136/bmjopen-2022-071063.

Randomised controlled trial of the effects of kefir on behaviour, sleep and the microbiome in children with ADHD: a study protocol

Kate Lawrence  1 , Philippa Fibert  2 , Jemima Hobbs  2 , Kyriaki Myrissa  2 , Miguel A Toribio-Mateas  3 , Frits Quadt  4 , Paul D Cotter  5   6   7 , Alice M Gregory  8
Affiliations

Randomised controlled trial of the effects of kefir on behaviour, sleep and the microbiome in children with ADHD: a study protocol

Kate Lawrence et al. BMJ Open. .

Abstract

Introduction: Current interventions for children with attention-deficit/hyperactivity disorder (ADHD) are primarily medication, behavioural therapy and parent training. However, research suggests dietary manipulations may provide therapeutic benefit for some. There is accumulating evidence that the gut microbiome may be atypical in ADHD, and therefore, manipulating gut bacteria in such individuals may help alleviate some of the symptoms of this condition. The aim of this study is to explore the effects of supplementation with kefir (a fermented dairy drink) on ADHD symptomatology, sleep, attention and the gut microbiome in children diagnosed with ADHD.

Methods and analysis: A 6-week randomised, double-blind, placebo-controlled trial in 70 children aged 8-13 years diagnosed with ADHD. Participants will be recruited throughout the UK, through support groups, community groups, schools, social media and word of mouth. Children will be randomised to consume daily either dairy kefir or a placebo dairy drink for 6 weeks. The primary outcome, ADHD symptomatology, will be measured by The Strengths and Weakness of ADHD-symptoms and Normal-behaviour scale. Secondary outcomes will include gut microbiota composition (using shotgun metagenomic microbiome sequencing), gut symptomatology (The Gastrointestinal Severity Index questionnaire), sleep (using 7-day actigraphy recordings, The Child's Sleep Habits Questionnaire and Sleep Self Report questionnaire), inattention and impulsivity (with a computerised Go/NoGo test). Assessments will be conducted prior to the intervention and at the end of the intervention. Interaction between time (preintervention/postintervention) and group (probiotic/placebo) is to be analysed using a Mixed Model Analysis of Variances.

Ethics and dissemination: Ethical approval for the study was granted by St Mary's University Ethics Committee. Results will be disseminated through peer-reviewed publications, presentations to the scientific community and support groups.

Trial registration number: NCT05155696.

Keywords: ADHD; Actigraphy; Attention Deficit Hyperactivity Disorder; children; diet; kefir; microbiome; microbiota; randomised controlled trial; sleep.

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Conflict of interest statement

Competing interests: Nourish Kefir will supply organic cow’s milk kefir for the study at a reduced cost. They exert no control over the publication of results. AMG is an advisor for a project initially sponsored by Johnson’s Baby. She is a consultant for Perrigo (2021+). She receives royalties for two books Nodding Off (Bloomsbury Sigma, 2018) and The Sleepy Pebble (Flying Eye, 2019). She has another contract with Lawrence King Publishers (publication due 2023). She was previously a CEO of Sleep Universal LTD (2022). She is a regular contributor to BBC Focus Magazine and has contributed to other outlets (such as The Conversation, The Guardian and Balance Magazine). She occasionally receives sample products related to sleep (eg, blue light blocking glasses) and has given a paid talk to a business (Investec). She is a specialist subject editor at JCPP (sleep) for which she receives a small honorarium. She has contributed a paid article to Neurodiem. KL previously held a paid role as Research Editor for Foodsmatter. She is an Editorial Board Member for the British Association of Nutritional and Lifestyle Medicine, Nutritional Evidence Database (NED) and a Scientific Advisory Board Member for Chuckling Goat, both in an unpaid capacity. She is occasionally paid, or receives hospitality, to deliver talks on her research and infrequently receives sample products related to health and nutrition. PDC is a cofounder and is the CTO of SeqBiome. He has also been occasionally paid, or received hospitality, to deliver talks on his research. MAT-M is Head of R&D for Chuckling Goat, and was previously employed by Atlas Biomed as Director of Health and Nutrition Research.

Figures

Figure 1
Figure 1
Flow diagram detailing ADHD study procedures. ADHD, attention-deficit/hyperactivity disorder.
See this image and copyright information in PMC

References

    1. Sayal K, Prasad V, Daley D, et al. ADHD in children and young people: prevalence, care pathways, and service provision. Lancet Psychiatry 2018;5:175–86. 10.1016/S2215-0366(17)30167-0 - DOI - PubMed
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders 5th ed. 22 May 2013. 10.1176/appi.books.9780890425596 - DOI
    1. Punja S, Shamseer L, Hartling L, et al. Amphetamines for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev 2016;2. 10.1002/14651858.CD009996.pub2 - DOI - PMC - PubMed
    1. Klein RG, Mannuzza S, Olazagasti MAR, et al. Clinical and functional outcome of childhood attention-deficit/ hyperactivity disorder 33 years later. Arch Gen Psychiatry 2012;69:1295. 10.1001/archgenpsychiatry.2012.271 - DOI - PMC - PubMed
    1. Owens JA. Sleep disorders and attention-deficit/hyperactivity disorder. Curr Psychiatry Rep 2008;10:439–44. 10.1007/s11920-008-0070-x - DOI - PubMed

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