The Role of Probiotics PS128 in Movement Disorders
关键词
抽象
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 8 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.
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 08/15/2017 |
| 提交的预估入学人数: | 08/20/2017 |
| 首次发布: | 08/23/2017 |
| 上次提交的更新: | 04/27/2020 |
| 最近更新发布: | 04/29/2020 |
| 实际学习开始日期: | 08/24/2017 |
| 预计主要完成日期: | 08/19/2020 |
| 预计完成日期: | 08/19/2021 |
状况或疾病
干预/治疗
Dietary Supplement: Probiotic-Lactobacillus plantarum PS128
Dietary Supplement: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: Placebo (for tic disorder) The placebo will be dispensed to equal the volume of 1 tablet of Probiotic PS128, which is taken orally in 2 divided doses, 12 hours apart during the study period of 2 months for Tic disorders. | |
| Active Comparator: PS128 (tic disorder) The Probiotic group in tic disorder will take Probiotic-Lactobacillus plantarum PS128, which contain 300mg (3x10^10 CFU) Lactobacillus plantarum PS128 and 100mg of Microcrystalline Cellulose in each tablet. It will be taken orally in 2 divided doses, 12 hours apart during the study period of 2 months for Tic disorders. | |
| Placebo Comparator: Placebo (for Rett syndrome) The placebo will be dispensed to equal the volume of 1 tablet of Probiotic PS128, which is taken orally in 2 divided doses, 12 hours apart during the study period of 4 months for Rett syndrome | |
| Active Comparator: PS128 (Rett syndrome) The Probiotic group will take Probiotic-Lactobacillus plantarum PS128, which contain 300mg (3x10^10 CFU) Lactobacillus plantarum PS128 and 100mg of Microcrystalline Cellulose in each tablet. It will be taken orally in 2 divided doses, 12 hours apart during the study period of 4 months for Rett Syndrome. |
资格标准
| 有资格学习的年龄 | 1 Year 至 1 Year |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. Neuropsychological test (Mullen Scales of Early Learning) [Change at four months from baseline]
2. Yale Global Tic Severity Scale (YGTSS) [Change at 2 months from baseline]
次要成果指标
1. RTT severity score [Change at four months from baseline]
2. Dystonia status (Fahn Marsden rating scale/Unified Dystonia Rating Scale ) [Visit 1, Visit 2, Visit 3, Visit 4 (Up to 4 months)]
3. Anxiety, Depression, and Mood Scale (ADAMS) [Change at four months from baseline]
4. Ghuman-Folstein Screen for Social Interaction (SSI) [Change at four months from baseline]
5. Vineland Adaptive Behavioral scale [Change at four months from baseline]
6. Early social communication scales [Change at four months from baseline]
7. Pediatric Evaluation of Disability Inventory [Change at four months from baseline]
8. Stool and gut microbiota evaluation [Change at four months from baseline]
9. Child Behavior Checklist (CBCL) [Change at 2 months from baseline]
10. Continuous performance test [Change at 2 months from baseline]
11. The Migraine Disability Assessment Test [Change at 2 months from baseline]
12. Children's Depression Inventory [Change at 2 months from baseline]
13. Obsessive-compulsive inventory [Change at 2 months from baseline]
14. Swanson, Nolan and Pehlam version IV [Change at 2 months from baseline]
