Clinical trial NCT06922773: Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity
Official title: Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Early Life Adversity
Microbiome, Human
Anxiety Symptoms
Depressive Symptoms
Posttraumatic Stress Symptoms
Keywords: early life adversity
gut microbiome
anxiety symptoms
depressive symptoms
posttraumatic stress symptoms
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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?


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

Primary outcomes:
measure: Global mental wellbeing
timeFrame: Assessment at enrollment
measure: Microbiomial diversity
timeFrame: Assessment based on single stool sample, within 4 weeks after enrollment
Secondary outcomes:
measure: Post-traumatic stress symptoms
timeFrame: Assessment at enrollment
measure: Anxiety and depression symptoms
timeFrame: Assessment at enrollment
measure: Firmicutes/Bacteroidetes ratio
timeFrame: Assessment based on single stool sample, within 4 weeks after enrollment
measure: Gut microbiomial composition
timeFrame: Assessment based on single stool sample, within 4 weeks after enrollment
measure: Short-chain fatty acid metabolites
timeFrame: Assessment based on single stool sample, within 4 weeks after enrollment
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
References: