The Role of Probiotics PS128 in Movement Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Neuropsychological test (Mullen Scales of Early Learning)
研究概览
简要总结
Pediatric movement disorders comprise of a large number of different neurological diseases including Rett syndrome (RTT) and Tourette syndrome. Studies in the literature as well as our preliminary reports showed that Rett syndrome and Tourette syndrome/Tic disorders are associated with a dysbiosis of the gut microbiota compared to normal control. Probiotic Lactobacillus plantarum PS128 is a diet supplement that available for human consumption. Probiotic Lactobacillus plantarum PS128 had showed psychotropic effects such as ameliorate anxiety- and depression-like behaviors as well as altered the level of neurotransmitters such as dopamine in the brain in animal models, which might be through microbiota-gut-brain axis. Therefore, the purpose of this study is to access the possible neurobehavior effects of Probiotic Lactobacillus plantarum PS128 in Rett syndrome and Tic disorders/Tourette syndrome.
详细描述
The study is a placebo-controlled double-blind randomized study, to determine the benefits of probiotic Lactobacillus plantarum PS128 vs placebo on symptoms for Tic disorders; and the symptoms, behavior, or cognition for Rett syndrome.
Patients with the Rett syndrome and Tic disorders/Tourette syndrome will be recruited into our study.The study period will last 4 months for Rett syndrome patients, age one year-50years; while 2 months for Tic disorders/Tourette syndrome patient, age 5 years-18 years.
The study will be performed in National Taiwan University Children Hospital. The patients will have neuropsychological and gut microbiota evaluation before and at the end of the study. There will also be interim follow up evaluations each month after the patient start taking the probiotic or placebo.
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
Randomized double blind placebo-controlled
入排标准
- 年龄范围
- 1 Year 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rett syndrome:
- •Males and females who have classic or atypical RTT diagnosed under consensus criteria
- •Age: 1-50 years
- •Tic disorders:
- •males and females with clinical diagnosis
- •Age: 8-18years
- •Treatment naive 4 weeks prior to study
- •Those with standard medications, dosage stable 4 weeks prior to study
- •AADC syndrome:
- •Males and females with AADC diagnosis
- •Age: 1-50 years
排除标准
- •Those who took probiotic or probiotic related product 4 weeks prior to the study or during the study
- •Those who took antibiotic 4 weeks prior to the study
- •Those showing poor compliance with any aspect of the study
- •Those had adverse reactions to PS128
结局指标
主要结局
Neuropsychological test (Mullen Scales of Early Learning)
时间窗: Change at four months from baseline
for Rett syndrome
Yale Global Tic Severity Scale (YGTSS)
时间窗: Change at 2 months from baseline
for Tic disorders
次要结局
- RTT severity score(Change at four months from baseline)
- Anxiety, Depression, and Mood Scale (ADAMS)(Change at four months from baseline)
- Children's Depression Inventory(Change at 2 months from baseline)
- Early social communication scales(Change at four months from baseline)
- The Migraine Disability Assessment Test(Change at 2 months from baseline)
- Dystonia status (Fahn Marsden rating scale/Unified Dystonia Rating Scale )(Visit 1, Visit 2, Visit 3, Visit 4 (Up to 4 months))
- Vineland Adaptive Behavioral scale(Change at four months from baseline)
- Pediatric Evaluation of Disability Inventory(Change at four months from baseline)
- Stool and gut microbiota evaluation(Change at four months from baseline)
- Child Behavior Checklist (CBCL)(Change at 2 months from baseline)
- Continuous performance test(Change at 2 months from baseline)
- Obsessive-compulsive inventory(Change at 2 months from baseline)
- Ghuman-Folstein Screen for Social Interaction (SSI)(Change at four months from baseline)
- Swanson, Nolan and Pehlam version IV(Change at 2 months from baseline)