Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized double-blind healthy control study and the implementation period is after Institutional Review Board (IRB) approval to December 31, 2022. 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.

Official Title
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Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome

Conditions
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Tourette's Syndrome

Intervention / Treatment
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* Dietary Supplement: PS128


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PS128<br>Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks. | Dietary Supplement: PS128<br>* 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<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks. | Dietary Supplement: PS128<br>* 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<br>* Other names: Placebo;|
| No Intervention: Healthy Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 12 Weeks Assessed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Youth Inventories (BYI-II) | The new Beck Youth Inventories™ 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) | 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 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 |