Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Brief summary
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
Interventions
DIETARY_SUPPLEMENTProbiotics
Probiotics in a sachet
DIETARY_SUPPLEMENTPlacebo
Placebo in a sachet
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Having taken prebiotic or probiotic treatment in the month prior to inclusion, or having taken antibiotics for more than one week in the 3 months prior to inclusion, * Taking part in another clinical trial or being in the exclusion period of a previous clinical trial, * Parents (legal representatives) presenting a psychological or linguistic incapability to sign the ICF, * Parents (legal representatives) impossible to contact in case of emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score | 12 weeks |
Countries
China
Contacts
CONTACTFeng Li, MD, PhD
Outcome results
None listed