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

NCT ID: NCT06922773

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-06-30

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Brussel

Jette, Brussels Capital, Belgium

Countries

Belgium

Central Contacts

Sam L.B. Bonduelle, Master of Medicine

Role: CONTACT

sam.bonduelle@uzbrussel.be

+32 2 474 97 27

Other Identifiers

23275_BELLYBRAIN

Identifier Type: -

Identifier Source: org_study_id