Effects of Probiotics on gut microbiota changes in Children with Attention Deficit/hyperactivity disorder: a double-blind, randomized, placebo-controlled trial
- Conditions
- Gut dysbiosis and ADHD symptoms in children with ADHDGastrointestinal MicrobiomeProbioticsAttention Deficit Disorder with Hyperactivity
- Registration Number
- TCTR20210211003
- Lead Sponsor
- Faculty of Medicine, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 60
1. Children fulfilled with DSM-5 criteria for ADHD and healthy children for control group, 2. Participant legally acceptable representative has provided written informed consent to study participation
1. Had a known neurodevelopmental disorders example for autistic spectrum disorder, global developmental delay, 2. Had a known chronic disorder requiring long term medication including cancers, autoimmune disorders, metabolic disorders or chronic neurological disorders including epilepsy, 3.History of received stimulant, sedative, antipsychotic, beta-blocker, calcium channel-blocker medications within 14 days prior to screening, 4.History of received oral antibiotics within 14 days prior to screening, 5. History of received prebiotics or probiotics within 14 days prior to screening, 6. Participants has a documented allergy, hypersensitivity, or intolerance to any of the ingredients of the intervention, 7 .Selective eating such as vegan, vegetarian
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gut microbiota at allocation time, at 1, 2, 3 month, and at 1 month after intervention Quantitative Polymerase Chain Reaction (qPCR)
- Secondary Outcome Measures
Name Time Method Symptoms of ADHD at allocation time, at 1, 2, 3 month, and at 1 month after intervention SNAP-IV, CGI-IS, CGI-I, PedsQL, SDQ, CSHQ