Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
This study investigates WecProB (Bifidobacterium animalis subsp. lactis and Lacticaseibacillus rhamnosus) to evaluate their potential to improve symptoms and safety in children with ADHD.
Interventions
DIETARY_SUPPLEMENTProbiotic
The experimental phase of the study had last 56 days, and each patient will make 3 visits (d0, d28, d56).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of ADHD per DSM-5 criteria; 2. Age 6-12 years, gender-neutral; 3. IQ \>70 on intelligence testing; 4. Participant/guardian comprehension and voluntary consent.
Exclusion criteria
1. Those with a clear history of other serious neurological diseases, such as epilepsy, head trauma, encephalitis or meningitis, etc.; 2. Have taken antibiotics, probiotics or immunosuppressants within one month before starting the experiment; 3. Ongoing special diet, such as ketogenic diet, etc 4. BMI higher than the 90th percentile or lower than the 10th percentile for children of the same age and sex; 5. Those who have had symptoms of respiratory or digestive tract infection in the past month, such as fever, cough, diarrhea, etc.; 6. Those who have had inflammatory bowel disease in the past, such as ulcerative colitis, Crohn's disease, etc.;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical symptoms of ADHD | 56 days | The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), was employed to assess the executive functioning deficits commonly associated with ADHD in children. The BRIEF-2 scale ranges from a minimum of 0 to a maximum of 300 points. Higher scores on the BRIEF-2 indicate greater executive dysfunction, meaning that a higher score reflects worse outcomes. |
Countries
China
Outcome results
None listed