Behaviour Clinical Trial
Official title:
Investigating the Effects of a Prebiotic Supplement on Learning and Behaviour in Children From Academic Year Groups 3, 4 and 5, Whose Reading Scores Suggest There is Room for Improvement: a Randomised Placebo-controlled Study
Recently, there has been an emerging interest in how manipulating gut microbiota (which is
composed by microorganisms living in our digestive system) can influence learning, memory and
cognition. This influence is thought to primarily occur via the gut endocrine and immune
systems, and the vagus nerve, all of which influence brain function and are modulated by
intestinal microorganisms. One way to manipulate the microbiota is to ingest dietary
compounds, such as prebiotics.
Prebiotics are non-digestible dietary fibres that enhance the growth of "healthy" bacteria in
the intestines when given in adequate amounts. Prebiotics are relatively stable, can be
stored at room temperature and can be easily added to foods or drinks. They are not degraded
by enzymes and acids in the digestive tract; therefore they reach the colon relatively
unchanged, where they are metabolised by specific bacteria, thus promoting their beneficial
effects. Prebiotics can be found in very small proportions in vegetables and fruits such as
leeks, onions, tomatoes, garlic, etc., but this naturally occurring quantity is generally
insufficient to promote a significant growth of beneficial bacteria. Therefore, large
quantities of purified prebiotics are available as powder supplements and sold in packages of
the appropriate dose.
Pre-clinical studies in animals have shown that prebiotics modulates brain expression of key
molecules involved in cognition and brain health in rats. These findings therefore highlight
the potential of influencing cognition through the manipulation of gut microbiota (in this
case, via the ingestion of a prebiotic).
Building on this evidence, the aim of this study is to investigate how manipulating gut
microbiota can influence reading, learning and behaviour in a group of children whose reading
scores suggest there is room for improvement.
This study has a randomised, double-blind, between-subjects, placebo-controlled design,
whereby participants will receive a 12-week treatment with Bimuno or a matched placebo.
Children whose Key Stage 1 scores indicate they are within the lowest quintile for literacy,
but whose teachers do not judge them to have any other significant learning difficulties,
will be invited to be screened for the study. The teacher will also need to confirm if their
reading is still a cause of concern; if not, the children will no longer be considered for
inclusion in the study. Teachers will be asked to add the names of any additional children
whose reading shows room for improvement. These children will be assessed to ensure they meet
inclusion/exclusion criteria.
If the child passes this initial school screening stage, and conditional to parental consent,
he/she will then be assessed using the reading test from the British Ability Scale (BAS).
Only those whose reading falls into the bottom 34th centile on the BAS word reading measure
will be invited to take part in the full study.
The study will include three sessions in total (all taking place at schools): (1) screening
session, (2) baseline session and (3) post-intervention testing session. Children will also
be asked to wear an actigraphy device for 5 consecutive nights before and after the
treatment. In addition, children will be asked to give saliva samples on a few occasions
(both at home - pre- and post-intervention -, as well as during the baseline and testing
session visits).
Parents and teachers will be asked to complete standardised questionnaires also before and
after the treatment ends.
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