A Double-Blind Placebo Controlled Study of Probiotic Supplement as Treatment for Students With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- Reduce symptoms of attention deficit measured by MOXO test
研究概览
简要总结
Subjects will answer the following questionnaire and tests:
- Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)
- Demographic Questionnaire - composed by the researchers
- Family Eating Habits Questionnaire (FEAHQ-33)
- Food Frequency Questionnaire (FFQ)
- Test MOXO
The subjects will take the study product for six months.
After six months the subject will fill once again all the questionnaires.
详细描述
Computerized performance test MOXO - the test has been developed in Israel by Neurotech Company. The test's goal is to assess and define a participant's performance according to the four indices of Attention Deficit Hyperactivity Disorder: Attention, Hyperactivity, Impulsivity, and Timing with adjustment for age.
Subjects will answer the following questionnaire and tests:
- Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)
- Demographic Questionnaire - composed by the researchers
- Family Eating Habits Questionnaire (FEAHQ-33)
- Food Frequency Questionnaire (FFQ)
- Test MOXO
The subjects will take the study product for six months.
After six months the subject will fill once again all the questionnaires.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students registered in the college's Support Center for Students with Learning Disabilities and who have been diagnosed by a computerized didactic assessment -MATAL - as well as an attention diagnosis by a psychiatrist or a neurologist,
- •Students who are not treated by medication or alternative treatment,
- •Students who are not due to complete their education at Tel Hai College during the study period,
- •Students who have signed on an informed consent form,
- •No dairy intolerance (student can consume milk without any adverse effects),
- •No soy allergy,
- •Not currently taking any antibiotics or probiotics,
- •Not pregnant or planning to become pregnant during the study period,
- •Not been diagnosed with any of the following:
- •Crohn's disease
- •Ulcerative colitis
- •Immune compromised illness
- •Other serious illness
排除标准
- •Students treated by any type of treatment for Attention Deficit Hyperactivity Disorder,
- •Students who have not been assessed by MATAL and a psychiatrist,
- •Students who take antibiotics.
结局指标
主要结局
Reduce symptoms of attention deficit measured by MOXO test
时间窗: Six month
After six month of treatment reduce symptoms of attention deficit will be measured by MOXO test
次要结局
未报告次要终点