Prebiotic powder to support sleep, mood, and thinking in 3–5-year-olds
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
Run by University of Reading · NCT07401212 · Data updated 2026-11-12
We will test whether taking 5 g/day of a prebiotic powder for 8 weeks helps sleep, temperament, emotion regulation, and thinking skills and changes gut bacteria in healthy 3–5‑year‑old children who eat less fiber than recommended.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 5 Years |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | University of Reading Academic / other |
| Locations | 1 site (Reading, Berkshire) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2027 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT07401212 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy children aged 3–5 years (36–71 months) whose daily fiber intake is below age-specific recommendations, without major chronic illnesses, and with no recent antibiotic or probiotic use are ideal candidates.
✕Probably not a fit
Children with significant chronic gastrointestinal, neurodevelopmental, immunological, psychiatric, or metabolic disorders, those with food allergies or intolerances, or those who recently used antibiotics or probiotic supplements are unlikely to benefit from this intervention as studied.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a double-blind, randomized, placebo-controlled parallel trial enrolling 106 children aged 3–5 years with lower-than-recommended dietary fiber intake. Participants are randomized to consume 5 g/day of a prebiotic powder or a matched placebo for 8 weeks, with cognitive and behavioral measures taken before and after supplementation. Stool samples are collected at baseline and week 8 to analyze microbiome diversity and composition. A 4-week washout is followed by online parent questionnaires at week 12 to capture any lasting changes.
Why it matters
Potential benefit: If successful, this could provide a simple, low-risk dietary approach to improve sleep, behavior, and cognitive outcomes in young children with low fiber intake.
How similar studies have gone: Some animal and adult studies suggest prebiotics can alter the microbiome and modestly affect mood or cognition, but clinical evidence in preschool-aged children is limited and inconsistent.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, United Kingdom Recruiting
Study contacts
- Study coordinator: Piril Hepsomali, PhD
- Email: p.hepsomali@reading.ac.uk
- Phone: +44 118 378 5818
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.