Status:
NOT_YET_RECRUITING
Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Early Life Adversity
Microbiome, Human
Eligibility:
All Genders
6-13 years
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06922773
Start Date
May 1 2025
End Date
June 1 2026
Last Update
April 10 2025
Active Locations (1)
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1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090