Using probiotics to help children with ADHD
Therapeutic Effects of Multiple-strain Probiotics for Children With ADHD Based on Assessment of Standardized Attention Tests and Quantitative Electroencephalogram: a Single Arm Pilot Study
This study is testing whether giving probiotics to children with ADHD can help improve their attention and brain activity while they are on their regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 11 Years |
| Sex | All |
| Sponsor | Tsyr-Huey Mental Hospital Academic / other |
| Locations | 1 site (Kaohsiung) |
| Trial ID | NCT06226584 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of multiple strains of probiotics on children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). It aims to provide objective data on the therapeutic potential of probiotics by utilizing standardized attention tests and quantitative electroencephalogram (qEEG) to assess changes in brain networks. The study focuses on children aged 8-11 who have been stable on their psychotropic medications for at least eight weeks. By measuring brain activity and attention, the researchers hope to gain insights into the efficacy of probiotics in managing ADHD symptoms.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-11 diagnosed with ADHD who are stable on their current psychotropic medications.
Not a fit: Patients with major mental or neurological disorders, serious gastrointestinal diseases, or those who have recently used antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a novel, non-pharmacological treatment option for children with ADHD.
How similar studies have performed: Previous studies have shown some promise in using probiotics for ADHD, but this approach utilizing qEEG is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A patient is eligible for the study if all of the followings apply: 1. 8-11 children diagnosed with ADHD by board certified pediatric psychiatrist according to DSM-5 (assessment tool using SNAP criteria, at least 6/9 symptoms of inattention and/or hyperactivity/impulsivity (≧2/3 on each severity scale) on parents' and teachers' observation) 2. On stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks Exclusion Criteria: Any patient meeting any of the exclusion criteria will be excluded from study participation: 1. Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc. 2. Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases. 3. Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month. 4. Participated in other clinical research in the past month. 5. Vegetarians or those currently undergoing special diet therapy. 6. Evaluation by the pediatric psychiatrist not suitable for entering the test
Where this trial is running
Kaohsiung
- Tsyr-HueyMentalHospital — Kaohsiung, Taiwan (Recruiting)
Study contacts
- Principal investigator: YU-SHIAN CHENG, MDPhD — Tsyr-Huey Mental Hospital
- Study coordinator: YU-SHIAN CHENG, MDPhD
- Email: n043283@gmail.com
- Phone: 00886978173901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.