Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
To evaluate whether supplementing with PS128 can improve the symptoms and quality of life related to Tourette's disease in children.
详细描述
This is a randomized double-blind healthy control study and the implementation period is after Institutional Review Board (IRB) approval to December 31, 2023.
Experimental group: 80 subjects who meet the criteria for the admission of Tourette's disease will be enrolled. They will consume the PS128 or placebo capsules every day, 2 capsules at a time, for 12 weeks. Healthy control group: 40 subjects of the same age as the experimental group will be included, without any intervention measures, only collect stool sample once.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 4-18 years old
- •Tourette's disease is diagnosed
- •Make sure it is not caused by medication or other diseases
- •Cause major interference in social interaction, study or work
- •The healthy control group is not diagnosed with Tourette's disease, and is judged by PI
排除标准
- •Have taken antibiotics within a month or are receiving antibiotic treatment
- •Used probiotic products in powder, capsule or tablet form within two weeks (except yogurt, yogurt, Yakult and other related foods)
- •Patients who have undergone hepatobiliary gastrointestinal surgery (except for colorectal polypectomy and appendectomy)
- •Inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
- •Those with a history of cancer
- •Those who are allergic to lactic acid bacteria products
- •Those who are not suitable to participate judged by PI
研究组 & 干预措施
PS128
Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks.
干预措施: PS128 (Dietary Supplement)
Placebo
Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks.
干预措施: PS128 (Dietary Supplement)
Healthy Control
结局指标
主要结局
Yale Global Tic Severity Scale (YGTSS)
时间窗: From Baseline to 4, 8, and 12 Weeks Assessed
The YGTSS scale refers to Yale Global Tic Severity Scale, and it is a rating tool used to gauge the course of Tourette's syndrome in patients.
次要结局
- Visual Analogue Scale for GI symptoms (VAS-GI)(From Baseline to 12 Weeks Assessed)
- Child Behavior Checklist (CBCL)(From Baseline to 12 Weeks Assessed)
- Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL)(From Baseline to 4, 8 and 12 Weeks Assessed)
- Gut microbiota(From Baseline to 12 Weeks Assessed)
- Beck Youth Inventories (BYI-II)(From Baseline to 12 Weeks Assessed)
- Attention-Deficit/Hyperactivity Disorder Test (ADHDT)(From Baseline to 12 Weeks Assessed)
- Autism Behavior Checklist-Taiwan Version (ABCT)(From Baseline to 12 Weeks Assessed)
- Clinical Global Impression Scale (CGI)(From Baseline to 4, 8 and 12 Weeks Assessed)
- miRNA(From Baseline to 12 Weeks Assessed)