NCT07401212

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

February 3, 2026

Last Update Submit

April 27, 2026

Conditions

TemperamentSleepCognitionEmotion Regulation

Keywords

prebioticsemotion regulationgut microbiome diversitychildrenrelative abundancesleepinternalising symptomsexternalising symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Emotion Regulation Skills Questionnaire

    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

    This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)

  • Bristol Stool Chart

    This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)

  • Gut microbiome diversity

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

  • Gut microbiome composition

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

Other Outcomes (8)

  • Attentional Control Scale

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

  • Difficulties in Emotional Regulation Scale

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

  • Patient Health Questionnaire-8

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

  • +5 more other outcomes

Study Arms (2)

Prebiotic (powder)

EXPERIMENTAL

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

Matched placebo (powder)

PLACEBO COMPARATOR

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

Interventions

Prebiotic powderDIETARY_SUPPLEMENT

5g of prebiotic fibre

Prebiotic (powder)
PlaceboDIETARY_SUPPLEMENT

5g of placebo

Matched placebo (powder)

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6BZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Central Study Contacts

Piril Hepsomali, PhD

CONTACT

+44 118 378 5818p.hepsomali@reading.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)