At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
1 other identifier
interventional
53
1 country
1
Brief Summary
This study aims to investigate how GOS food supplement influences the gut-microbiome-brain axis to improve emotion regulation skills and cognition in a sample of children and adolescents (aged 6-14 years).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
1 active site
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 Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedFebruary 14, 2024
February 1, 2024
10 months
February 6, 2024
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in trait anxiety.
Self report instrument: state-trait anxiety measure for children (STAIC) - Trait scale.
End of treatment (4 weeks), Follow up (8 weeks).
Changes in emotion processing.
Performance on behavioural task: emotional dot-probe task.
End of treatment (4 weeks), Follow up (8 weeks).
Secondary Outcomes (3)
Changes in depression.
End of treatment (4 weeks), Follow up (8 weeks).
Changes in attention networks.
End of treatment (4 weeks), Follow up (8 weeks).
Changes in nutrient intake
End of treatment (4 weeks), Follow up (8 weeks).
Other Outcomes (4)
Parental anxiety: covariate of child outcome.
Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Parental emotion processing: covariate of child outcome.
Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Parent depression
Baseline, End of treatment (4 weeks), Follow up (8 weeks).
- +1 more other outcomes
Study Arms (2)
Treatment
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Typically developing, healthy male or female aged 6-14 years
- Access to home laptop/ personal computer
You may not qualify if:
- Current clinical levels of anxiety and/or co-morbid psychological diagnoses
- Neuro/developmental disorders
- Gastro-intestinal problems or disease
- Restrictive diets (e.g., lactose intolerance, gluten free)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Surreylead
- FrieslandCampinacollaborator
Study Sites (1)
University of Surrey
Guildford, Surrey, GU2 7XH, United Kingdom
Related Publications (1)
Johnstone N, Cohen Kadosh K. Indicators of improved emotion behavior in 6-14-year-old children following a 4-week placebo controlled prebiotic supplement intervention at home with a parent. Nutr J. 2025 Mar 1;24(1):34. doi: 10.1186/s12937-025-01098-5.
PMID: 40025494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2024
First Posted
February 14, 2024
Study Start
February 1, 2021
Primary Completion
December 1, 2021
Study Completion
March 1, 2022
Last Updated
February 14, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share