Children with attention-deficit/hyperactivity disorder (ADHD)
Conditions
Interventions
Intervention group:Study subjects will receive SCM06 for 6 weeks
Sponsors
JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Children and adolescents aged between 6-17 years; 2. Chinese ethnicity; 3. Documented ADHD in clinical or assessment records by a physician or qualified professional for at least one year; 4. SWAN parent-report subscale scores >= 0.75 on either the Inattention subscale OR the Hyperactivity-Impulsivity subscale; 5. Stable condition for non-medical interventions/training such as physiotherapists, occupational therapists, special training for at least 6 months assessed by the investigators; 6. Similar diet pattern in the last 4 weeks and agree to maintain the same pattern throughout the study period; 7. Parent/caregiver willing to complete questionnaires and comply with study procedures; 8. Written minor informed consent from parent/legal guardian and assent from child (if >=8 years); 9. Normal growth parameters (between 2nd to 98th centile for age-specific weight and height)
Exclusion criteria
Exclusion criteria: 1. Gastrointestinal disorders requiring ongoing medical treatment; 2. Significant comorbid psychiatric conditions requiring medication changes; 3. Use of ADHD medication, unless on a stable dose in the last 2 weeks; 4. Recent use of antibiotics, probiotics, or prebiotics within 4 weeks; 5. Known allergy or intolerance to study components; 6. Inability to receive oral fluids; 7. Participation in other interventional clinical trials within 30 days; 8. Planned drug holiday (skip taking the ADHD medications temporarily) for 14 consecutive days or more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in condition; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ADHD symptom severity;Changes in health-related quality of life;Changes in gastrointestinal symptoms;Changes in gut microbiome composition and functions; | — |
Countries
China
Contacts
Public ContactWONG Chi-sang
JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Outcome results
None listed