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

NCT06922773 | Not Yet Recruiting

• 1 other identifier: 23275_BELLYBRAIN
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Keywords

early life adversity; gut microbiome; anxiety symptoms; depressive symptoms; posttraumatic stress symptoms

Outcome Measures

Primary Outcomes (2)

• Global mental wellbeing

  KIDSCREEN-10 total score

  Assessment at enrollment

• Microbiomial diversity

  Gut microbiomial beta-diversity, based on UniFrac and Bray-Curtis distance index

  Assessment based on single stool sample, within 4 weeks after enrollment

Secondary Outcomes (5)

• Post-traumatic stress symptoms

  Assessment at enrollment

• Anxiety and depression symptoms

  Assessment at enrollment

• Firmicutes/Bacteroidetes ratio

  Assessment based on single stool sample, within 4 weeks after enrollment

• Gut microbiomial composition

  Assessment based on single stool sample, within 4 weeks after enrollment

• Short-chain fatty acid metabolites

  Assessment based on single stool sample, within 4 weeks after enrollment

Interventions

Completion of questionnaires; child psychiatric screening; faecal sample analysis DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Primary school-aged children (6 to 13 years of age) who have been referred to the UZ Brussel child and adolescent psychiatry department

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal sample

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Sam L.B. Bonduelle, Master of Medicine

CONTACT

+32 2 474 97 27; sam.bonduelle@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

BE (1)