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NCT06922773 | NOT YET RECRUITING | Early Life Adversity


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

University Hospital Brussels

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?

Condition or disease

Early Life Adversity

Microbiome, Human

Anxiety Symptoms

Depressive Symptoms

Posttraumatic Stress Symptoms

Intervention/treatment

Completion of questionnaires; child psychiatric screening; faecal sample analysis

Study Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
Official Title : Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years to 13 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT06922773


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How to Participate

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Locations


Not yet recruiting

Belgium, Brussels

Already brussel

Throw, Brussels, Belgium, 1090

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