An interventional study of PS128 in Tourette's Syndrome, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 4 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Other
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.
220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.
This study's enrollment of 121 is above the median of 34 across 166 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks.
Dietary Supplement: PS128
Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks.
Dietary Supplement: PS128
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
Also known as: Placebo
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.
Time frame: From Baseline to 4, 8, and 12 Weeks Assessed
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: From Baseline to 4, 8 and 12 Weeks Assessed
miRNA
peripheral blood miRNA expressions
Time frame: From Baseline to 12 Weeks Assessed
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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China Medical University Hospital