Behaviour Clinical Trial
— OxPiCOfficial 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
Verified date | March 2018 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 10 Years |
Eligibility |
Inclusion Criteria: Children - Children from academic year groups 3, 4 and 5 (who are generally aged 7 to 9 years), male or female, who are underperforming in literacy skills according to nationally standardised assessments of scholastic achievement at age 7 (Key Stage 1). To be eligible, children must be confirmed to score = 34th centile for reading, but are not judged by their teachers to have any other significant learning difficulties; - Children are willing and able to give informed assent for participation in the study and to comply with all study requirements; - Fluent English speakers only, as the measures have only been validated on such children. Parents - Parents of those children selected to do the study (after doing the screening reading test), and who are willing and able to give informed consent and to comply with all study requirements; - Fluent English speakers only, as the measures have only been validated on such adults. Teachers • Primary school teachers of children who are selected to do the study, and who are willing and able to give informed consent and to comply with all study requirements. Exclusion Criteria: Children - Major learning disabilities or medical disorders (including diseases affecting the human gastrointestinal tract); - Participants who are currently taking (or intending to take) any medication that may affect the outcomes, including medications affecting brain processing, sedation, gut health and motility (examples include antidepressants, anxiolytics, cholinergic agonists, among others); - Participants who have a known intolerance to lactose; - Participants who are taking any other food supplements which, in the opinion of the Investigators, may affect the results; - Antibiotic, probiotic and/or prebiotic treatment in at least the 2 previous months; - Any significant change in diet which, to the discretion of the Investigators, may affect the results; - Participants who have recently participated in another research trial which, to the discretion of the Investigators, may affect the results; - Any firm plans of the child and family to move schools during the intervention period; - Any other significant finding arising during the screening/selection process which, in the opinion of the Investigators, may influence the participant's ability to take part in the study or the study results. Parents • Lack of availability to comply with study procedures. Teachers • Lack of availability to comply with study procedures. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford University Department of Psychiatry | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Clasado Biosciences Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | British Ability Scale (BAS) II Word Scale | 12 weeks | ||
Primary | British Ability Scale (BAS) Digit Span Scale | 12 weeks | ||
Primary | CogTrack Precision Cognitive Tests | 12 weeks | ||
Secondary | State-Trait Anxiety Inventory for children - child's version | 12 weeks | ||
Secondary | State-Trait Anxiety Inventory for children - parent's version | 12 weeks | ||
Secondary | Mood and Feelings Questionnaire - child's version | 12 weeks | ||
Secondary | Mood and Feelings Questionnaire - parent's version | 12 weeks | ||
Secondary | Child Sleep Habits Questionnaire (CSHQ) | 12 weeks | ||
Secondary | Objective sleep as measured by actigraphy | 12 weeks | ||
Secondary | Gastro-intestinal function diary | 12 weeks | ||
Secondary | Sleep diary | 12 weeks | ||
Secondary | Conners Teacher Rating Scale (CTRS-L) | 12 weeks | ||
Secondary | Conners Parent Rating Scale (CPRS-L) | 12 weeks | ||
Secondary | Saliva samples (to measure cortisol and immune markers) | 12 weeks | ||
Secondary | School attendance | 12 weeks |
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