Tourette's Syndrome
Conditions
Brief summary
To evaluate whether supplementing with PS128 can improve the symptoms and quality of life related to Tourette's disease in children.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPS128
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
Sponsors
China Medical University Hospital
Bened Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Global Tic Severity Scale (YGTSS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Youth Inventories (BYI-II) | From Baseline to 12 Weeks Assessed | 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. |
| Attention-Deficit/Hyperactivity Disorder Test (ADHDT) | From Baseline to 12 Weeks Assessed | The test yields standard scores, percentile ranks, severity levels, and probability of ADHD. |
| Child Behavior Checklist (CBCL) | From Baseline to 12 Weeks Assessed | 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. |
| Autism Behavior Checklist-Taiwan Version (ABCT) | From Baseline to 12 Weeks Assessed | 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. |
| Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL) | From Baseline to 4, 8 and 12 Weeks Assessed | 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. |
| Gut microbiota | From Baseline to 12 Weeks Assessed | 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. |
| Clinical Global Impression Scale (CGI) | From Baseline to 4, 8 and 12 Weeks Assessed | 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). |
| Visual Analogue Scale for GI symptoms (VAS-GI) | From Baseline to 12 Weeks Assessed | 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. |
| miRNA | From Baseline to 12 Weeks Assessed | peripheral blood miRNA expressions |
Countries
Taiwan
Outcome results
None listed