Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Completion of questionnaires; child psychiatric screening; faecal sample analysis.
- Who it may be relevant to
- Registry conditions: Early Life Adversity, Microbiome, Human, Anxiety Symptoms, Depressive Symptoms. Basic parameters: 6 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test 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(
Primary outcome measures
- Global mental wellbeing [Time frame: Assessment at enrollment]
- Microbiomial diversity [Time frame: Assessment based on single stool sample, within 4 weeks after enrollment]
Secondary outcome measures (5)
- Post-traumatic stress symptoms [Time frame: Assessment at enrollment]
- Anxiety and depression symptoms [Time frame: Assessment at enrollment]
- Firmicutes/Bacteroidetes ratio [Time frame: Assessment based on single stool sample, within 4 weeks after enrollment]
- Gut microbiomial composition [Time frame: Assessment based on single stool sample, within 4 weeks after enrollment]
- Short-chain fatty acid metabolites [Time frame: Assessment based on single stool sample, within 4 weeks after enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- UZ Brussel — Jette
Identifiers
NCT: NCT06922773 · 23275_BELLYBRAIN