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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The Swanson, Nolan and Pelham Chinese (SNAP) rating scales
研究概览
简要总结
Probiotics are widely used as supplement for various neurodevelopmental disorders. The mechanism of their therapeutic potential lies in the "gut-brain axis", a two-way communication pathway through the neuroendocrine system. In the past, there have been many experiments to study the possible efficacy of probiotics in patients with ADHD. Although some studies have shown that probiotics can improve ADHD symptoms, most studies have used behavioral rating scales to evaluate. As a result, it is susceptible to informant bias. Standardized attentional tests and quantitative electroencephalogram (qEEG) can provide more objective data and detect possible changes in brain networks. Such changes may precede behavioral phenotypes. Therefore, the purpose of this study is mainly to detect the therapeutic effect of multiple strains of probiotics in patients with attention deficit hyperactivity disorder by using standardized attention tests and quantified brain waves (qEEG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient is eligible for the study if all of the followings apply:
- •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)
- •On stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks
排除标准
- •Any patient meeting any of the exclusion criteria will be excluded from study participation:
- •Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc.
- •Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases.
- •Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month.
- •Participated in other clinical research in the past month.
- •Vegetarians or those currently undergoing special diet therapy.
- •Evaluation by the pediatric psychiatrist not suitable for entering the test
结局指标
主要结局
The Swanson, Nolan and Pelham Chinese (SNAP) rating scales
时间窗: every one month for 3 months
for behavioral symptoms of ADHD, the minimum and maximum values (0-78), higher scores mean a worse outcome
quantitative electroencephalogram
时间窗: pre- and post-intervention (3 months)
measurement of brain wave patterns and coherence
Conners' Continuous Performance Test 3rd Edition
时间窗: pre- and post-intervention (3 months)
a task-oriented computerised assessment of attention-related problems in individuals aged 8 years and older
次要结局
- adverse events(every one month for 3 months)
研究者
Cheng Yu-Shian
Psychiatrist
Tsyr-Huey Mental Hospital