An interventional study of Prebiotic powder and Placebo in Temperament, Sleep and Cognition, sponsored by University of Reading. Recruiting at 1 site in United Kingdom. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of Reading · Not applicable, Interventional, and Basic science
This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.
This study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 8-week-long prebiotic consumption on cognitive, behavioural, and gut microbiome, outcomes in 3-5-year-old children with insufficient fibre intake (less than the average 10.4g/day in 18-47-month-olds and less than 12.6g/day in 48-60-month-olds). One hundred and six participants will be randomised to Intervention or Placebo groups where they will be consuming 5g of prebiotic fibre or 5g of placebo (matched placebo powder) per day for 8-weeks. Outcome measures will be acquired before and after a 8-week chronic supplementation. These will include cognitive and behavioural outcomes of the parents and children. In addition, stool samples will be collected at the baseline and at week 8 to assess microbiome diversity and composition. Additionally, after 4-weeks of wash-out, at 12 weeks, parents will be asked to completed online questionnaires assessing cognitive and behavioural outcome of their children.
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 106 is above the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children will consume two (one in the morning and one in the evening) 2.5g of prebiotic sachets a day (mixed with food and drink).
Dietary Supplement: Prebiotic powder
Children will consume two (one in the morning and one in the evening) 2.5g of placebo sachets a day (mixed with food and drink).
Dietary Supplement: Placebo
5g of prebiotic fibre
5g of placebo
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)
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)
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)
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)
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).
Gut microbiome composition
Children's stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).
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).
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).
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).
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).
Child-Parent Relationship Scale
Parents will be asked to complete this measure that includes 30 items that assesses their relationship with their child/children.
Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).
Scottish Collaborative Group Child VC2 Food Frequency Questionnaire
Parents will be asked to complete this measure that assesses their child's habitual food intake.
Time frame: This measure will be taken at baseline (pre intervention).
Child Eating Behaviour Questionnaire
Parents will be asked to complete this measure that assesses their child's eating behaviour.
Time frame: This measure will be taken at baseline (pre intervention).
Dietary recall
This measure will be used to screen participants. Parents will be asked to complete this measure that assesses their child's food intake. Children with insufficient fibre intake (less than the average 10.4g/day in 18-47-month-olds and less than 12.6g/day in 48-60-month-olds) will be eligible for the study.
Time frame: This measure will be taken during screening and at week 8 (post intervention).
Plan to share: No
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Studies of the drug tested here: Prebiotics