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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Symptoms; Posttraumatic Stress Symptoms; Anxiety Symptoms; Early Life Adversity; Microbiome, Human
• Intervention / Treatment: Diagnostic test: Completion of questionnaires; child psychiatric screening; faecal sample analysis

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Sam L.B. Bonduelle, Master of Medicine; Phone Number: +32 2 474 97 27; Email: sam.bonduelle@uzbrussel.be

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: gut microbiome; depressive symptoms; anxiety symptoms; posttraumatic stress symptoms; early life adversity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 23275_BELLYBRAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No