Completed

Lactobacillus Plantarum PS128 Impact on Tourette's Syndrome

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Study Aim

This study investigates how Lactobacillus Plantarum PS128 affects individuals with Tourette's Syndrome, primarily focusing on the severity of tics as measured by the Yale Global Tic Severity Scale.

What is being tested

PS128

Dietary Supplement
Who is being recruted

Basal Ganglia Diseases+10

+ Mental Disorders

+ Brain Diseases

From 4 to 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: November 2021
See protocol details

Summary

Principal SponsorChina Medical University Hospital
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 29, 2021

Actual date on which the first participant was enrolled.

This study focuses on understanding the effects of a specific bacteria, Lactobacillus Plantarum PS128, in individuals with Tourette's Syndrome. Tourette's Syndrome is a neurological condition characterized by repetitive, stereotyped, involuntary movements and vocalizations called tics. The study aims to enroll 80 subjects who meet the criteria for Tourette's Syndrome, with the hope of finding a new way to manage the symptoms of this condition. The study also includes a healthy control group of 40 subjects of the same age, to compare results. Participants with Tourette's Syndrome will consume either PS128 or a placebo capsule every day, two capsules at a time, for a period of 12 weeks. The healthy control group will not receive any intervention, but will provide a stool sample once. The study's primary outcome is measured using the Yale Global Tic Severity Scale (YGTSS), a tool used to evaluate the severity of tics in people with Tourette's Syndrome. This scale helps researchers determine if the PS128 capsules have any effect on reducing the severity of tics.

Official TitleEffects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome
NCT04805385
Principal SponsorChina Medical University Hospital
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

121 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Basal Ganglia DiseasesMental DisordersBrain DiseasesCentral Nervous System DiseasesTourette SyndromeMovement DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesTic DisordersNeurodegenerative DiseasesHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornNeurodevelopmental Disorders

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
7 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

China Medical University Hospital

Taichung, TaiwanOpen China Medical University Hospital in Google Maps
CompletedOne Study Center