GUTLINK4KIDS Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prebiotic powder, Placebo.
- Who it may be relevant to
- Registry conditions: Temperament, Sleep, Cognition, Emotion Regulation. Basic parameters: 3 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Chronic Consumption of Prebiotics on Cognitive and Affective Outcomes, Gut Microbiome Diversity and Composition in 3-5 Year Olds: a Double-blind Placebo-controlled, Parallel-groups Randomised Controlled Trial
Overview
This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.
Detailed description
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.
Interventions
- Dietary supplement Prebiotic powder
5g of prebiotic fibre - Dietary supplement Placebo
5g of placebo
Primary outcome measures
- Child Behaviour Checklist Ages 1.5-5 [Time frame: This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)]
Secondary outcome measures (5)
- Emotion Regulation Skills Questionnaire [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 [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 [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 [Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).]
- Gut microbiome composition [Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United Kingdom · 1 center
- University of Reading, School of Psychology and Clinical Languages — Reading
Identifiers
NCT: NCT07401212 · UREC25_38