NCT06922773

Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about the effects of early-life adversity (ELA) on the composition of children's microbiome and on their psychosocial functioning. The main questions it aims to answer are: * Do children who have experienced ELA have lower gut microbial diversity and/or an altered gut microbial composition? * Do these microbiome alterations correlate with adverse neurodevelopmental outcomes, including increased levels of stress, social and/or affective problems?

Conditions

• Early Life Adversity
• Microbiome, Human
• Anxiety Symptoms
• Depressive Symptoms
• Posttraumatic Stress Symptoms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Completion of questionnaires; child psychiatric screening; faecal sample analysis	Completion of questionnaires: * FFQ (Food Frequency Questionnaire) - completed by child * KIDSCREEN-10 - completed by child * CRIES-13 (Child Revised Impact of Events Scale) - completed by parents/guardian and child * CTES (Childhood Trust Events Survey) - completed by parents/guardian * RCADS-25 (Revised Children's Anxiety and Depression Scale) - completed by parents/guardian and child Child psychiatric screening using SCID-5-Junior - semi-structured interview conducted with child and parent(s)/guardian Faecal sample analysis: * Beta-diversity (UniFrac and Bray-Curtis distance index) * Firmicutes/Bacteroidetes ratio * Abundance of Prevotella, Lactobacillaceae, Bifidobacteriacae and Lachnospiraceae * Short-chain fatty acid metabolites

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2025-04-10
• Last updated: 2025-04-10

Locations

1 site across 1 country: Belgium