Effect of Bifidobacterium Bifidum (Bf-688) on Clinical Characteristics and Gut Microbiota in Attention-deficit/Hyperactivity Disorder: a Double-blind Randomized-control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Kiddie-Schedule for Affective Disorder and Schizophrenia-Epidemiological Ver- sion (K-SADS-E)
研究概览
简要总结
Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder. Gut microbiome dysbiosis may be associated with the pathophysiology of ADHD. Investigators previously found the relative abundance of Sutterella stercoricanis were increased and Bifidobacterium bifidum were decreased in the ADHD group. Investigators hypothesize that ADHD patients receiving supplementary Bifidobacterium bifidum (Bf-688) is able to increase the proportion of Bf-688; inhibit the proportion of Sutterella; and improve ADHD symptoms.
详细描述
Aims:
Investigators will conduct an open-label, single arm study and a randomized, double-blind clinical trial to examine whether Bf-688 can achieve similar effects to therapeutic drugs for ADHD.
Methods:
The duration of this clinical trial is expected to be 2 years (March 2020 to February 2022).
- In the first stage of study, investigators will conduct an open-label, single arm study. Investigators will recruit 30 children aged 4-16 who are diagnosed as ADHD who are eligible to participate in the trial. The patients will be administrated with Bf-688, 1 pack each morning and evening (5×109 colony forming units (CFUs) per day) for 8 weeks. At the baseline, 2nd, 4th and 8th week, the clinical symptoms of ADHD will be evaluated using the SNAP-IV and ADHD-RS. At weeks 0 and 8, blood samples and fecal samples will be collected and psychological tests will be performed.
- In the second stage of study, This clinical trial is a prospective, randomized, double-blind, parallel-controlled clinical trial for children aged 6-12 years old who are diagnosis of ADHD and who are currently receiving ADHD drug therapy. A total of 120 patients will be recruited in this trial. All subjects will be randomly assigned (allocation ratio 1:1) to one of the following two groups (60 people in each group):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Developmental Delay
- •Vegetarian
研究组 & 干预措施
Probiotics group
Probiotics
Candidates conditions excluded:
- 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 that will affect the results of intestinal microflora assessment
- Have received ADHD-related drug treatment (containing Methylphenidate or Atomoxetine) in the past month.
- 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 host is not suitable for entering the test.
干预措施: BF688 (Other)
Control group
Placebo
Candidates conditions excluded:
- 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 that will affect the results of intestinal microflora assessment
- Have received ADHD-related drug treatment (containing Methylphenidate or Atomoxetine) in the past month.
- 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 host is not suitable for entering the test.
干预措施: Placebo (Drug)
结局指标
主要结局
Kiddie-Schedule for Affective Disorder and Schizophrenia-Epidemiological Ver- sion (K-SADS-E)
时间窗: At the baseline
screening
The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)
时间窗: 8th week
ADHD
次要结局
未报告次要终点
研究者
Wang Liang-Jen
Professor and Visiting Staff
Chang Gung Memorial Hospital