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

Not yet recruiting

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

• Registration Number: NCT06922773
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Study Start: 2025-05
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Primary school-aged children (6 to 13 years of age) who have experienced at least one early-life traumatic event, based on the Childhood Trust Events Survey (CTES) questionnaire
• The child and at least one of his/her parents (or guardian) speak Dutch sufficiently well to complete all of the questionnaires and the semi-structured child psychiatric interview (SCID-5-Junior)

Exclusion Criteria

• any chronic disorders or diseases known to affect the gut micobiome
• inablity to complete questionnaires and/or semi-structured interview because of linguistic and/or cognitive barrier
• congenital or acquired immunodeficiencies
• use of medication(s) that affect gastrointestinal function (e.g., antibiotics) within the last 6 weeks, or laxatives within the last 4 weeks, or probiotic or prebiotic supplements within the last 4 weeks
• current involvement in another clinical or food study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global mental wellbeing	Assessment at enrollment	KIDSCREEN-10 total score
Microbiomial diversity	Assessment based on single stool sample, within 4 weeks after enrollment	Gut microbiomial beta-diversity, based on UniFrac and Bray-Curtis distance index

Secondary Outcome Measures

Name	Time	Method
Post-traumatic stress symptoms	Assessment at enrollment	CRIES-13 (Child Revised Impact of Events Scale) total scores, based on parent version and based on child version
Anxiety and depression symptoms	Assessment at enrollment	RCADS-25 (Revised Children's Anxiety and Depression Scale) total scores, based on parent version and child version
Firmicutes/Bacteroidetes ratio	Assessment based on single stool sample, within 4 weeks after enrollment	Gut microbiomial Firmicutes/Bacteroidetes ratio
Gut microbiomial composition	Assessment based on single stool sample, within 4 weeks after enrollment	Gut microbiomial abundance of Prevotella, Lactobacillaceae, Bifidobacteriacae and Lachnospiraceae
Short-chain fatty acid metabolites	Assessment based on single stool sample, within 4 weeks after enrollment	Gut microbiomial short-chain fatty acid metabolites

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussels, Belgium