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

University of Surrey

Status: Completed

Conditions: Emotional Regulation

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Galacto-oligosaccharide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06258135

FearlessStudy4

Details and patient eligibility

About

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).

Enrollment: 53 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Treatment:

Dietary Supplement: Galacto-oligosaccharide

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Maltodextrin