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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-13
SponsorUniversitair Ziekenhuis Brussel

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Global mental wellbeing

KIDSCREEN-10 total score

Time frame
Assessment at enrollment
2

Microbiomial diversity

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

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

Secondary outcomes

1

Post-traumatic stress symptoms

CRIES-13 (Child Revised Impact of Events Scale) total scores, based on parent version and based on child version

Time frame
Assessment at enrollment
2

Anxiety and depression symptoms

RCADS-25 (Revised Children's Anxiety and Depression Scale) total scores, based on parent version and child version

Time frame
Assessment at enrollment
3

Firmicutes/Bacteroidetes ratio

Gut microbiomial Firmicutes/Bacteroidetes ratio

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

Gut microbiomial composition

Gut microbiomial abundance of Prevotella, Lactobacillaceae, Bifidobacteriacae and Lachnospiraceae

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

Other outcomes

Sponsors and contacts

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