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

U

Universitair Ziekenhuis Brussel

Status

Not yet enrolling

Conditions

Depressive Symptoms
Anxiety Symptoms
Microbiome, Human
Early Life Adversity
Posttraumatic Stress Symptoms

Treatments

Diagnostic Test: Completion of questionnaires; child psychiatric screening; faecal sample analysis

Study type

Observational

Funder types

Other

Identifiers

NCT06922773
23275_BELLYBRAIN

Details and patient eligibility

About

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?

Enrollment

50 estimated patients

Sex

All

Ages

6 to 13 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Sam L.B. Bonduelle, Master of Medicine

Data sourced from clinicaltrials.gov

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