NCT07401212

GUTLINK4KIDS Intervention

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Temperament
• Sleep
• Cognition
• Emotion Regulation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic powder	5g of prebiotic fibre
DIETARY_SUPPLEMENT	Placebo	5g of placebo

Timeline

• Start date: 2026-03-02
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2026-02-10
• Last updated: 2026-03-02

Locations

1 site across 1 country: United Kingdom