At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06258135

Enrollment

Registered

2024-02-14

Start date

2021-02-01

Completion date

2022-03-01

Last updated

2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Regulation

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).

Interventions

DIETARY_SUPPLEMENTGalacto-oligosaccharide

Single 7g dose daily for 28 days

DIETARY_SUPPLEMENTMaltodextrin

Single 7g dose daily for 28 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

* Typically developing, healthy male or female aged 6-14 years * Access to home laptop/ personal computer

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame	Description
Changes in trait anxiety.	End of treatment (4 weeks), Follow up (8 weeks).	Self report instrument: state-trait anxiety measure for children (STAIC) - Trait scale.
Changes in emotion processing.	End of treatment (4 weeks), Follow up (8 weeks).	Performance on behavioural task: emotional dot-probe task.

Secondary

Measure	Time frame	Description
Changes in depression.	End of treatment (4 weeks), Follow up (8 weeks).	Self report instrument: child depression inventory (CDI).
Changes in attention networks.	End of treatment (4 weeks), Follow up (8 weeks).	Performance on behavioural task: attention network test (ANT) adapted for use by children.
Changes in nutrient intake	End of treatment (4 weeks), Follow up (8 weeks).	Self report instrument: food diary completed over 4 days, average intakes calculated.

Other

Measure	Time frame	Description
Parent depression	Baseline, End of treatment (4 weeks), Follow up (8 weeks).	Self report instrument: Becks depression inventory (BDI-II).
Parental emotion processing: covariate of child outcome.	Baseline, End of treatment (4 weeks), Follow up (8 weeks).	Performance on behavioural task: emotional dot-probe task.
Parent attention networks	Baseline, End of treatment (4 weeks), Follow up (8 weeks).	Performance on behavioural task: attention network test.
Parental anxiety: covariate of child outcome.	Baseline, End of treatment (4 weeks), Follow up (8 weeks).	Self report instrument: state-trait anxiety inventory (STAI) - Trait scale.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026