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 volunteersQualifiers
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
Case-only
Prospective
Treatments tested in this trial
Completion of questionnaires; child psychiatric screening; faecal sample analysis
Diagnostic testCompletion 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
Trial outcomes
Primary outcomes
Global mental wellbeing
KIDSCREEN-10 total score
Microbiomial diversity
Gut microbiomial beta-diversity, based on UniFrac and Bray-Curtis distance index
Secondary outcomes
Post-traumatic stress symptoms
CRIES-13 (Child Revised Impact of Events Scale) total scores, based on parent version and based on child version
Anxiety and depression symptoms
RCADS-25 (Revised Children's Anxiety and Depression Scale) total scores, based on parent version and child version
Firmicutes/Bacteroidetes ratio
Gut microbiomial Firmicutes/Bacteroidetes ratio
Gut microbiomial composition
Gut microbiomial abundance of Prevotella, Lactobacillaceae, Bifidobacteriacae and Lachnospiraceae
Sponsors and contacts
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