Lawrence, Kate; Myrissa, Kyriaki; Toribio-Mateas, Miguel; Minini, Lori and Gregory, Alice M.. 2022. Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility study. Pilot and Feasibility Studies, 8, 108. ISSN 2055-5784 [Article]

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Abstract or Description

Background
Dietary interventions have been previously explored in children with ADHD. Elimination diets and supplementation can produce beneficial behaviour changes, but little is known about the mechanisms mediating change. We propose that these interventions may work, in part, by causing changes in the gut microbiota. A microbiome-targeted dietary intervention was developed, and its feasibility assessed.

Methods
A non-randomised feasibility study was conducted on nine non-medicated children with ADHD, aged 8–13 years (mean 10.39 years), using a prospective one-group pre-test/post-test design. Participants were recruited from ADHD support groups in London and took part in the 6-week microbiome-targeted dietary intervention, which was specifically designed to impact the composition of gut bacteria. Children were assessed pre- and post-intervention on measures of ADHD symptomatology, cognition, sleep, gut function and stool-sample microbiome analysis. The primary aim was to assess the study completion rate, with secondary aims assessing adherence, adverse events (aiming for no severe and minimal), acceptability and suitability of outcome measures.

Results
Recruitment proved to be challenging and despite targeting 230 participants directly through support groups, and many more through social media, nine families (of the planned 10) signed up for the trial. The completion rate for the study was excellent at 100%. Exploration of secondary aims revealed that (1) adherence to each aspect of the dietary protocol was very good; (2) two mild adverse events were reported; (3) parents rated the treatment as having good acceptability; (4) data collection and outcome measures were broadly feasible for use in an RCT with a few suggestions recommended; (5) descriptive data for outcome measures is presented and suggests that further exploration of gut microbiota, ADHD symptoms and sleep would be helpful in future research.

Conclusions
This study provides preliminary evidence for the feasibility of a microbiome-targeted dietary intervention in children with ADHD. Recruitment was challenging, but the diet itself was well-tolerated and adherence was very good. Families wishing to trial this diet may find it an acceptable intervention. However, recruitment, even for this small pilot study, was challenging. Because of the difficulty experienced recruiting participants, future randomised controlled trials may wish to adopt a simpler dietary approach which requires less parental time and engagement, in order to recruit the number of participants required to make meaningful statistical interpretations of efficacy.

Item Type:	Article
Identification Number (DOI):	https://doi.org/10.1186/s40814-022-01058-4
Additional Information:	he online version of the article contains supplementary material available at https://doi.org/10.1186/s40814‑022‑01058‑4. This research and the APC was supported by a Child Development Fund Research Grant from The Waterloo Foundation, (grant number 1961/3248)
Keywords:	Actigraphy, Attention‑deficit hyperactivity disorder, ADHD, Children, Diet, Feasibility study, Kefir, Microbiome, Microbiota, Sleep
Departments, Centres and Research Units:	Psychology
Dates:	Date Event 23 May 2022 Published 3 May 2022 Accepted
Item ID:	31865
Date Deposited:	23 May 2022 10:53
Last Modified:	23 May 2022 10:53
Peer Reviewed:	Yes, this version has been peer-reviewed.
URI:	https://research.gold.ac.uk/id/eprint/31865

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