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

NCT04805385 | Completed DMC

• 1 other identifier: CMUH109-REC2-188
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tourette's Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 4, 8, and 12 Weeks Assessed

Secondary Outcomes (9)

• Beck Youth Inventories (BYI-II)

  From Baseline to 12 Weeks Assessed

• Attention-Deficit/Hyperactivity Disorder Test (ADHDT)

  From Baseline to 12 Weeks Assessed

• Child Behavior Checklist (CBCL)

  From Baseline to 12 Weeks Assessed

• Autism Behavior Checklist-Taiwan Version (ABCT)

  From Baseline to 12 Weeks Assessed

• Visual Analogue Scale for GI symptoms (VAS-GI)

  From Baseline to 12 Weeks Assessed

Study Arms (3)

PS128

EXPERIMENTAL

Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks.

Dietary Supplement: PS128

Placebo

PLACEBO COMPARATOR

Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks.

Dietary Supplement: PS128

Healthy Control

NO INTERVENTION

Interventions

PS128 DIETARY_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

Also known as: Placebo

PS128; Placebo

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 404332, Taiwan

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 18, 2021
• Study Start: November 29, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

TW (1)