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NCT Number: NCT06922773

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

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?

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Key information

Conditions

Early Life Adversity Anxiety Disorders Anxiety Symptoms Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders Microbiome, Human Posttraumatic Stress Symptoms

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Completion of questionnaires; child psychiatric screening; faecal sample analysis

Diagnostic Test

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(s)/guardian

Faecal sample analysis:

  • Beta-diversity (UniFrac and Bray-Curtis distance index)
  • Firmicutes/Bacteroidetes ratio
  • Abundance of Prevotella, Lactobacillaceae, Bifidobacteriacae and Lachnospiraceae
  • Short-chain fatty acid metabolites

Primary outcomes

  1. Global mental wellbeing

    Time frame: Assessment at enrollment

    KIDSCREEN-10 total score

  2. Microbiomial diversity

    Time frame: Assessment based on single stool sample, within 4 weeks after enrollment

    Gut microbiomial beta-diversity, based on UniFrac and Bray-Curtis distance index

Secondary outcomes

  1. Post-traumatic stress symptoms

    Time frame: Assessment at enrollment

    CRIES-13 (Child Revised Impact of Events Scale) total scores, based on parent version and based on child version

  2. Anxiety and depression symptoms

    Time frame: Assessment at enrollment

    RCADS-25 (Revised Children's Anxiety and Depression Scale) total scores, based on parent version and child version

  3. Firmicutes/Bacteroidetes ratio

    Time frame: Assessment based on single stool sample, within 4 weeks after enrollment

    Gut microbiomial Firmicutes/Bacteroidetes ratio

  4. Gut microbiomial composition

    Time frame: Assessment based on single stool sample, within 4 weeks after enrollment

    Gut microbiomial abundance of Prevotella, Lactobacillaceae, Bifidobacteriacae and Lachnospiraceae

  5. Short-chain fatty acid metabolites

    Time frame: Assessment based on single stool sample, within 4 weeks after enrollment

    Gut microbiomial short-chain fatty acid metabolites

Study contacts

Contact information is provided by the study sponsor or research team.

Sam L.B. Bonduelle, Master of Medicine

CONTACT

[email protected]

+32 2 474 97 27

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Acronym: BellyBrain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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