Investigating the Effectiveness of Probiotic Supplement in Improving Attention Deficit Hyperactivity Disorder Symptoms in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The severity of the Attention-deficit hyperactivity disorder (ADHD)
研究概览
简要总结
To study the effects of probiotic supplement in children with Attention-deficit hyperactivity disorder (ADHD),40 patients will be randomly allocated to two groups of intervention and placebo. The intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. Treatment efficacy will be assessed via administrating the Conners's rating
详细描述
Both probiotics and placebo groups will receive medication with Ritalin in a dose-dependent manner, starting at the onset of the study and simultaneous with probiotic supplementation. Children weighed 30 Kg or less receive 0.3 mg/kg of Ritalin in 3 separate intervals and after four weeks the dosage will increase to 0.5mg/kg. Those who weighed more than 30 kg receive 0.5 mg/kg with the same pattern that reaches the highest point of 0.7 mg/kg by week four. Each dosage will be administrated trice a day with breakfast, lunch, and dinner. In the middle of the study patients who consumes less than 80% of their supplements will be omitted from the study.
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)
盲法说明
Both patients and researchers won't be aware of the treatments patients receiving in this study (unaware of the quiddity of A and B capsules), so the study has a double-blind design. Only one of the staff of the company that supplied the Probiotic supplement is aware of the type of assigned intervention for each patient. After collecting the data, he will unseal the codes for researchers, the statistical analyst, participants and those who prepare the manuscript.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Attention Deficit Hyperactivity Disorder
- •Having an Intelligence quotient more than 85 based on Wechsler test for children
- •Willing to participate in the study
排除标准
- •History of any other mental and psychological disorder such as depression, chronic motor tic disorder, communication disorder, learning disability
- •Taking any stimulant, sedative, anti-anxiety and anti-psychotic medications
- •History of any chronic disorders, requiring long term medication (such as cancers, Cirrhosis, autoimmune disorders, metabolic disorders ) or, chronic neurological disorders (such as epilepsy)
结局指标
主要结局
The severity of the Attention-deficit hyperactivity disorder (ADHD)
时间窗: 8 weeks
The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test
symptoms of Attention-deficit hyperactivity disorder (ADHD)
时间窗: 8 weeks
symptoms were assessed using Conners's scale
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
Principal Investigator
National Nutrition and Food Technology Institute