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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06922773
Acronym
BellyBrain
Enrollment
50
Registered
2025-04-10
Start date
2025-05-31
Completion date
2026-06-30
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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?

Interventions

DIAGNOSTIC_TESTCompletion 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

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Global mental wellbeingAssessment at enrollmentKIDSCREEN-10 total score
Microbiomial diversityAssessment based on single stool sample, within 4 weeks after enrollmentGut microbiomial beta-diversity, based on UniFrac and Bray-Curtis distance index

Secondary

MeasureTime frameDescription
Post-traumatic stress symptomsAssessment at enrollmentCRIES-13 (Child Revised Impact of Events Scale) total scores, based on parent version and based on child version
Gut microbiomial compositionAssessment based on single stool sample, within 4 weeks after enrollmentGut microbiomial abundance of Prevotella, Lactobacillaceae, Bifidobacteriacae and Lachnospiraceae
Firmicutes/Bacteroidetes ratioAssessment based on single stool sample, within 4 weeks after enrollmentGut microbiomial Firmicutes/Bacteroidetes ratio
Anxiety and depression symptomsAssessment at enrollmentRCADS-25 (Revised Children's Anxiety and Depression Scale) total scores, based on parent version and child version
Short-chain fatty acid metabolitesAssessment based on single stool sample, within 4 weeks after enrollmentGut microbiomial short-chain fatty acid metabolites

Countries

Belgium

Contacts

Primary ContactSam L.B. Bonduelle, Master of Medicine
sam.bonduelle@uzbrussel.be+32 2 474 97 27

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026