Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome
- Conditions
- Tourette's Syndrome
- Interventions
- Dietary Supplement: PS128
- Registration Number
- NCT04805385
- Lead Sponsor
- China Medical University Hospital
- 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, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PS128 PS128 Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks. Placebo PS128 Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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).
Trial Locations
- Locations (1)
China Medical University Hospital
🇨🇳Taichung, Taiwan