Early Life AdversityBellyBrainNCT06922773
Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity
An observational study of Early Life Adversity and Microbiome, Human, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Early Life Adversity, Microbiome, Human, Anxiety Symptoms
- What is being tested?
- Completion of questionnaires; child psychiatric screening; faecal sample analysis
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- May 2025to Jun 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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?
- Conditions
- Early Life Adversity, Microbiome, Human, Anxiety Symptoms, Depressive Symptoms, Posttraumatic Stress Symptoms
- Being tested
- Completion of questionnaires; child psychiatric screening; faecal sample analysis
- Keywords
- early life adversity, gut microbiome, anxiety symptoms, depressive symptoms, posttraumatic stress symptoms
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of questionnaires; child psychiatric screening; faecal sample analysisDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Global mental wellbeing
KIDSCREEN-10 total score
Measured: Assessment at enrollment
Microbiomial diversity
Gut microbiomial beta-diversity, based on UniFrac and Bray-Curtis distance index
Measured: Assessment based on single stool sample, within 4 weeks after enrollment
Secondary outcomes (5)
Post-traumatic stress symptoms
CRIES-13 (Child Revised Impact of Events Scale) total scores, based on parent version and based on child version
Measured: Assessment at enrollment
Anxiety and depression symptoms
RCADS-25 (Revised Children's Anxiety and Depression Scale) total scores, based on parent version and child version
Measured: Assessment at enrollment
Firmicutes/Bacteroidetes ratio
Gut microbiomial Firmicutes/Bacteroidetes ratio
Measured: Assessment based on single stool sample, within 4 weeks after enrollment
Gut microbiomial composition
Gut microbiomial abundance of Prevotella, Lactobacillaceae, Bifidobacteriacae and Lachnospiraceae
Measured: Assessment based on single stool sample, within 4 weeks after enrollment
Short-chain fatty acid metabolites
Gut microbiomial short-chain fatty acid metabolites
Measured: Assessment based on single stool sample, within 4 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Life AdversityStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922773
- Sponsor's protocol ID
- 23275_BELLYBRAIN
- Acronym
- BellyBrain
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity
- ClinicalTrials.gov ID
- NCT06922773
- Acronym / sponsor ID
- BellyBrain / 23275_BELLYBRAIN
- Conditions
- Early Life Adversity, Microbiome, Human, Anxiety Symptoms, Depressive Symptoms, Posttraumatic Stress Symptoms
- Keywords
- early life adversity, gut microbiome, anxiety symptoms, depressive symptoms, posttraumatic stress symptoms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion of questionnaires; child psychiatric screening; faecal sample analysisCompletion 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 | Diagnostic test | – |
Primary outcome
Global mental wellbeing
Time frame: Assessment at enrollment
KIDSCREEN-10 total score
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
5 secondary outcomes
Post-traumatic stress symptoms
Time frame: Assessment at enrollment
Anxiety and depression symptoms
Time frame: Assessment at enrollment
Firmicutes/Bacteroidetes ratio
Time frame: 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
Short-chain fatty acid metabolites
Time frame: Assessment based on single stool sample, within 4 weeks after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Related trials for Early Life Adversity
RecruitingPhase 1/2
Study of Cannabidiol and Neuroimaging on Stress
Early Life Adversity, Trauma
Recruiting
Integrated Suicide & Trauma Therapy for Suicide Risk
Suicide, Trauma
Recruiting
Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression
Depression - Major Depressive Disorder, Childhood Traumas
Recruiting
Modular Intervention for Depression Study
Major Depression
Recruiting
Positive Affect Treatment for Adolescents With Early Life Adversity
Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Life Adversity and Microbiome, Human, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sam L.B. Bonduelle, Master of Medicine (+32 2 474 97 27, sam.bonduelle@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global mental wellbeing (time frame: Assessment at enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.