BehaviourOxPiCNCT02926508
Oxford Study of Prebiotics in Children
A study testing Bimuno (BGOS) and Maltodextrin in people with Behaviour, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Behaviour
- What is being tested?
- Bimuno (BGOS) and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Department of Psychiatry
Oxford, Oxfordshire, OX3 7JX
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Behaviour
- Being tested
- Bimuno (BGOS), Maltodextrin
- Keywords
- Reading, Learning, Cognition
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MaltodextrinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic (Bimuno) | Experimental | Bimuno (B-GOS, Galacto-oligosaccharides, produced and provided by Clasado BioSciences Ltd) Receives: Dietary Supplement: Bimuno (BGOS) |
| Placebo | Placebo comparator | Maltodextrin Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
British Ability Scale (BAS) II Word Scale
Measured: 12 weeks
British Ability Scale (BAS) Digit Span Scale
Measured: 12 weeks
CogTrack Precision Cognitive Tests
Measured: 12 weeks
Secondary outcomes (12)
State-Trait Anxiety Inventory for children - child's version
Measured: 12 weeks
State-Trait Anxiety Inventory for children - parent's version
Measured: 12 weeks
Mood and Feelings Questionnaire - child's version
Measured: 12 weeks
Mood and Feelings Questionnaire - parent's version
Measured: 12 weeks
Child Sleep Habits Questionnaire (CSHQ)
Measured: 12 weeks
Objective sleep as measured by actigraphy
Measured: 12 weeks
Gastro-intestinal function diary
Measured: 12 weeks
Sleep diary
Measured: 12 weeks
Conners Teacher Rating Scale (CTRS-L)
Measured: 12 weeks
Conners Parent Rating Scale (CPRS-L)
Measured: 12 weeks
Saliva samples (to measure cortisol and immune markers)
Measured: 12 weeks
School attendance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviourStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Clasado Biosciences Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926508
- Sponsor's protocol ID
- R44843/RE001
- Acronym
- OxPiC
- Status last verified
- Mar 2018
- First submitted
- 18 Aug 2016
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02926508
- Acronym / sponsor ID
- OxPiC / R44843/RE001
- Conditions
- Behaviour
- Keywords
- Reading, Learning, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Clasado Biosciences Ltd
- Study start
- Jul 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic (Bimuno) | Experimental | Dietary Supplement: Bimuno (BGOS)Bimuno (B-GOS, Galacto-oligosaccharides, produced and provided by Clasado BioSciences Ltd) |
| Placebo | Placebo comparator | Other: MaltodextrinMaltodextrin |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Prebiotic (Bimuno) |
| MaltodextrinMaltodextrin 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. | Other | Placebo |
Primary outcome
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
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Behaviour
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bimuno (BGOS) and Maltodextrin in people with Behaviour, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
British Ability Scale (BAS) II Word Scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.