GUTLINK4KIDS Intervention (GUTLINK4KIDS)

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

This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Emotion Regulation; Cognition; Temperament
• Intervention / Treatment: Dietary supplement: Prebiotic powder; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Piril Hepsomali, PhD; Phone Number: +44 118 378 5818; Email: p.hepsomali@reading.ac.uk

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6BZ
      • Recruiting
      • University of Reading, School of Psychology and Clinical Languages
      • Contact: Piril Hepsomali, PhD; Phone Number: +44 118 378 5818; Email: p.hepsomali@reading.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prebiotic (powder); 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; 5g of prebiotic fibre
Placebo Comparator: Matched placebo (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 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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).	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).	This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional Control Scale	Parents will be asked to complete this measure that includes 20 items that assesses their own attentional control.	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.	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.	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.	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.	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.	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.	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.	This measure will be taken during screening and at week 8 (post intervention).

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: Beneo GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sleep; children; prebiotics; emotion regulation; gut microbiome diversity; relative abundance; internalising symptoms; externalising symptoms
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Self-Control; Emotional Regulation
• Other Study ID Numbers: UREC25_38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No