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NCT Number: NCT07401212

GUTLINK4KIDS Intervention

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

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Key information

Conditions

Temperament Behavior Cognition Emotion Regulation Emotional Regulation Self-Control Sleep Social Behavior

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6BZ, United Kingdom

Location status: Recruiting

Location contact

Piril Hepsomali, PhD

CONTACT

[email protected]

+44 118 378 5818

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotic powder

Dietary Supplement

5g of prebiotic fibre

Placebo

Dietary Supplement

5g of placebo

Primary outcomes

  1. 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)

    Parents will be asked to complete this validated measure that includes 100 items that assesses a child's emotional, behavioral, and social problems.

Secondary outcomes

  1. 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)

    Parents will be asked to complete this measure that includes 52 items that assesses a child's adaptive and maladaptive emotion regulation skills.

  2. 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)

    Parents will be asked to complete this measure that includes 44 items that assesses a child's developmental differences in social and communication functioning

  3. 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)

    Parents will be asked to complete this measure that includes 1 item that assesses a child's stool consistency.

  4. Gut microbiome diversity

    Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

    Children's stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).

  5. Gut microbiome composition

    Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

    Children's stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).

Other outcomes

  1. Attentional Control Scale

    Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

    Parents will be asked to complete this measure that includes 20 items that assesses their own attentional control.

  2. Difficulties in Emotional Regulation Scale

    Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

    Parents will be asked to complete this measure that includes 36 items that assesses their own emotion regulation skills.

  3. Patient Health Questionnaire-8

    Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

    Parents will be asked to complete this measure that includes 8 items that assesses their own depressed mood.

  4. Generalised Anxiety Disorder-7

    Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

    Parents will be asked to complete this measure that includes 7 items that assesses their own anxious mood.

  5. Child-Parent Relationship Scale

    Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

    Parents will be asked to complete this measure that includes 30 items that assesses their relationship with their child/children.

  6. Scottish Collaborative Group Child VC2 Food Frequency Questionnaire

    Time frame: This measure will be taken at baseline (pre intervention).

    Parents will be asked to complete this measure that assesses their child's habitual food intake.

  7. Child Eating Behaviour Questionnaire

    Time frame: This measure will be taken at baseline (pre intervention).

    Parents will be asked to complete this measure that assesses their child's eating behaviour.

  8. Dietary recall

    Time frame: This measure will be taken during screening and at week 8 (post intervention).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Piril Hepsomali, PhD

CONTACT

[email protected]

+44 118 378 5818

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Beneo GmbH

Registry information

Official study 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

Acronym: GUTLINK4KIDS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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