Effects of Probiotics on the Gut-brain Axis in Children
Randomised, Placebo-controlled Pilot Study to Assess the Effects of Probiotics on the Gut-brain Axis in Children With Attention Deficit Hyperactivity Disorder
1 other identifier
interventional
80
1 country
1
Brief Summary
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
March 10, 2026
March 1, 2026
1.6 years
March 5, 2026
March 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
12 weeks
Study Arms (2)
Probiotics
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Males and females aged 8 - 11 years
- With mild ADHD symptoms
- Patient and parents (legal representatives) able and willing to participate in the research by complying with the protocol procedures
You may not qualify if:
- Metabolic disorder
- Severe chronic disease
- GI disorders found to be inconsistent with the conduct of the study by the investigator
- Neurological disorder involving central function (e.g., intellectual disability, autism spectrum disorder, epilepsy, narcolepsy)
- Currently treated with a medication with primary central nervous system activity or major psychiatric condition requiring hospitalization
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients
- Parents (legal representatives) presenting a psychological or linguistic incapability to sign the ICF,
- Parents (legal representatives) impossible to contact in case of emergency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Probi ABlead
Study Sites (1)
Department of Developmental and Behavioral Pediatrics & Child Health Care Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 10, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share