GUTLINK4KIDS Intervention (GUTLINK4KIDS)

April 27, 2026 updated by: Piril Hepsomali, University of Reading

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6BZ
        • Recruiting
        • University of Reading, School of Psychology and Clinical Languages
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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
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.
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).
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
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).
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).
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.
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).
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.
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).
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.
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).
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.
This measure will be taken at baseline (pre intervention) and week 8 (post intervention).
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.
This measure will be taken at baseline (pre intervention).
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.
This measure will be taken at baseline (pre intervention).
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.
This measure will be taken during screening and at week 8 (post intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Reading

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beneo GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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