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| Name | Class |
|---|---|
| Bened Biomedical Co., Ltd. | INDUSTRY |
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To evaluate whether supplementing with PS128 can improve the symptoms and quality of life related to Tourette's disease in children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS128 | Experimental | Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks. |
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| Placebo | Placebo Comparator | Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks. |
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| Healthy Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PS128 | Dietary Supplement | Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose |
| Measure | Description | Time Frame |
|---|---|---|
| Yale Global Tic Severity Scale (YGTSS) | 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. | From Baseline to 4, 8, and 12 Weeks Assessed |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Youth Inventories (BYI-II) | The new Beck Youth Inventoriesâ„¢ Second Edition (BYI-2) uses five self-report inventories to assess symptoms of depression, anxiety, anger, disruptive behavior, and self-concept in children and adolescents. | From Baseline to 12 Weeks Assessed |
| Attention-Deficit/Hyperactivity Disorder Test (ADHDT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | 404332 | Taiwan |
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| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
The test yields standard scores, percentile ranks, severity levels, and probability of ADHD. |
| From Baseline to 12 Weeks Assessed |
| Child Behavior Checklist (CBCL) | The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. It is widely used in both research and clinical practice with youths. | From Baseline to 12 Weeks Assessed |
| Autism Behavior Checklist-Taiwan Version (ABCT) | The Autism Behavior Checklist (ABC) is one component of the Autism Screening Instrument for Educational Planning (ASIEP) and is the only one that has been evaluated psychometrically. The ABC is a 57-item behavior rating scale assessing the behaviors and symptoms of autism for children 3 and older. | From Baseline to 12 Weeks Assessed |
| Visual Analogue Scale for GI symptoms (VAS-GI) | Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking PS128. | From Baseline to 12 Weeks Assessed |
| Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL) | The Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL) is a self-rated disease-specific questionnaire to assess health-related quality of life of subjects with GTS. | From Baseline to 4, 8 and 12 Weeks Assessed |
| Gut microbiota | Intestinal microbiota may contribute to the metabolic health of the human host and, when aberrant, to the pathogenesis of various common metabolic disorders including obesity, type 2 diabetes, non-alcoholic liver disease, cardio-metabolic diseases and malnutrition. | From Baseline to 12 Weeks Assessed |
| Clinical Global Impression Scale (CGI) | Clinical Global Impression Scale (CGI) severity item provided with a seven-point scale of severity of the patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients). | From Baseline to 4, 8 and 12 Weeks Assessed |
| miRNA | peripheral blood miRNA expressions | From Baseline to 12 Weeks Assessed |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |