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

To evaluate whether supplementing with PS128 can improve the symptoms and quality of life related to Tourette's disease in children.

Study Overview

• Status: Recruiting
• Conditions: Tourette's Syndrome
• Intervention / Treatment: Dietary supplement: PS128

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: I-Ching Chou, MD; Phone Number: 4641 +886 4 22052121; Email: iching@mail.cmu.edu.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 404332
    • Recruiting
    • China Medical University Hospital
    • Contact: I-Ching Chou, MD; Phone Number: 4641 +886 4 22052121; Email: iching@mail.cmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy Control
Experimental: PS128; Subjects will consume the PS128 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; Other Names: Placebo
Placebo Comparator: Placebo; 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; Other Names: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: Bened Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 28, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: CMUH109-REC2-188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No