Oxford Study of Prebiotics in Children

NCT02926508 | Unknown DMC

• 1 other identifier: R44843/RE001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behaviour

Keywords

Reading; Learning; Cognition

Outcome Measures

Primary Outcomes (3)

• British Ability Scale (BAS) II Word Scale

  12 weeks

• British Ability Scale (BAS) Digit Span Scale

  12 weeks

• CogTrack Precision Cognitive Tests

  12 weeks

Secondary Outcomes (12)

• State-Trait Anxiety Inventory for children - child's version

  12 weeks

• State-Trait Anxiety Inventory for children - parent's version

  12 weeks

• Mood and Feelings Questionnaire - child's version

  12 weeks

• Mood and Feelings Questionnaire - parent's version

  12 weeks

• Child Sleep Habits Questionnaire (CSHQ)

  12 weeks

Study Arms (2)

Prebiotic (Bimuno)

EXPERIMENTAL

Bimuno (B-GOS, Galacto-oligosaccharides, produced and provided by Clasado BioSciences Ltd)

Dietary Supplement: Bimuno (BGOS)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Other: Maltodextrin

Interventions

Bimuno (BGOS) DIETARY_SUPPLEMENT

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.

Prebiotic (Bimuno)

Maltodextrin OTHER

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.

Placebo

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Clasado Biosciences Ltd: collaborator

Study Sites (1)

Oxford University Department of Psychiatry

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Behavior

Interventions

maltodextrin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: October 6, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 16, 2018

Record last verified: 2018-03

Locations

GB (1)