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

April 3, 2025 updated by: Universitair Ziekenhuis Brussel

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • UZ Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global mental wellbeing
Time Frame: Assessment at enrollment
KIDSCREEN-10 total score
Assessment at enrollment
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
Assessment based on single stool sample, within 4 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment at enrollment
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
Assessment at enrollment
Firmicutes/Bacteroidetes ratio
Time Frame: Assessment based on single stool sample, within 4 weeks after enrollment
Gut microbiomial Firmicutes/Bacteroidetes ratio
Assessment based on single stool sample, within 4 weeks after enrollment
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
Assessment based on single stool sample, within 4 weeks after enrollment
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
Assessment based on single stool sample, within 4 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23275_BELLYBRAIN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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