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

China Medical University Hospital121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

121

Conditions

Tourette's Syndrome

Interventions

PS128DIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

China Medical University Hospital

Taichung, Taiwan

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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