GUTLINK4KIDS Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-5
SponsorUniversity of Reading
About this trial
This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parents (18 years and over) of generally healthy children aged 3-5-years-old (36-71 months) with lower dietary fibre intake than the recommended daily amount (10.4g/day in 18-47-month-olds and less than 12.6g/day in 48-60-month-olds).
Disqualifiers
Children with a significant acute or chronic co-existing illness (including inflammatory bowel disease, functional gastrointestinal disorders, coeliac disease etc, neurodevelopmental, immunological, psychiatric, or metabolic disorders.
Children who have taken any pre/probiotic supplements or antibiotic treatment within the 4 weeks prior to enrolment.
Children with food allergies and intolerances
Trial design
Design model
Parallel
Treatments tested in this trial
Prebiotic powder
Dietary supplement5g of prebiotic fibre
Placebo
Dietary supplement5g of placebo
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Prebiotic (powder)Experimental treatment 1 intervention
Group B: Matched placebo (powder)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Child Behaviour Checklist Ages 1.5-5
Parents will be asked to complete this validated measure that includes 100 items that assesses a child's emotional, behavioral, and social problems.
Time frame
This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)Secondary outcomes
1
Emotion Regulation Skills Questionnaire
Parents will be asked to complete this measure that includes 52 items that assesses a child's adaptive and maladaptive emotion regulation skills.
Time frame
This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)2
Childhood Autism Spectrum Test
Parents will be asked to complete this measure that includes 44 items that assesses a child's developmental differences in social and communication functioning
Time frame
This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)3
Bristol Stool Chart
Parents will be asked to complete this measure that includes 1 item that assesses a child's stool consistency.
Time frame
This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)4
Gut microbiome diversity
Children's stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).
Time frame
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).Other outcomes
1
Attentional Control Scale
Parents will be asked to complete this measure that includes 20 items that assesses their own attentional control.
Time frame
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).2
Difficulties in Emotional Regulation Scale
Parents will be asked to complete this measure that includes 36 items that assesses their own emotion regulation skills.
Time frame
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).3
Patient Health Questionnaire-8
Parents will be asked to complete this measure that includes 8 items that assesses their own depressed mood.
Time frame
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).4
Generalised Anxiety Disorder-7
Parents will be asked to complete this measure that includes 7 items that assesses their own anxious mood.
Time frame
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Reading
Lead sponsor
Beneo GmbH
Collaborator
Source ClinicalTrials.gov