Oxford Study of Prebiotics in Children (OxPiC)
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|ClinicalTrials.gov Identifier: NCT02926508|
Recruitment Status : Enrolling by invitation
First Posted : October 6, 2016
Last Update Posted : March 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Behaviour||Dietary Supplement: Bimuno (BGOS) Other: Maltodextrin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Prebiotic (Bimuno)
Bimuno (B-GOS, Galacto-oligosaccharides, produced and provided by Clasado BioSciences Ltd)
Dietary Supplement: Bimuno (BGOS)
The active supplement of the food supplement (Bimuno) used in this study is called galacto‐oliogosaccharides (Bimuno®, BGOS). BGOS is a compound metabolised by specific bifidobacteria, which are beneficial bacteria, in our colon. Bimuno (2.3 calories) is composed by the following ingredients per gram of Bimuno: 0.96g dry matter; <01g Fat; <0.06g Protein; 0.821g GOS; 0.119g Lactose; 0.0331g Glucose and 0.0029g Galactose. Bimuno is tasteless.
Bimuno will be supplied in coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink.
Placebo Comparator: Placebo
Maltodextrin is a polysaccharide in powder form, which grows most bacteria in the gut, and not specifically the beneficial bifidobacteria.
The placebo will also be provided in daily coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink.
This placebo has been used in previous studies, in which Bimuno was used as the active intervention. The placebo will be similar in taste and colour to the active intervention.
- British Ability Scale (BAS) II Word Scale [ Time Frame: 12 weeks ]
- British Ability Scale (BAS) Digit Span Scale [ Time Frame: 12 weeks ]
- CogTrack Precision Cognitive Tests [ Time Frame: 12 weeks ]
- State-Trait Anxiety Inventory for children - child's version [ Time Frame: 12 weeks ]
- State-Trait Anxiety Inventory for children - parent's version [ Time Frame: 12 weeks ]
- Mood and Feelings Questionnaire - child's version [ Time Frame: 12 weeks ]
- Mood and Feelings Questionnaire - parent's version [ Time Frame: 12 weeks ]
- Child Sleep Habits Questionnaire (CSHQ) [ Time Frame: 12 weeks ]
- Objective sleep as measured by actigraphy [ Time Frame: 12 weeks ]
- Gastro-intestinal function diary [ Time Frame: 12 weeks ]
- Sleep diary [ Time Frame: 12 weeks ]
- Conners Teacher Rating Scale (CTRS-L) [ Time Frame: 12 weeks ]
- Conners Parent Rating Scale (CPRS-L) [ Time Frame: 12 weeks ]
- Saliva samples (to measure cortisol and immune markers) [ Time Frame: 12 weeks ]
- School attendance [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926508
|Oxford University Department of Psychiatry|
|Oxford, Oxfordshire, United Kingdom, OX3 7JX|