Tourette's SyndromeNCT04805385
Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome
A study testing PS128 in people with Tourette's Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
To evaluate whether supplementing with PS128 can improve the symptoms and quality of life related to Tourette's disease in children. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette's Syndrome
- What is being tested?
- PS128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Nov 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate whether supplementing with PS128 can improve the symptoms and quality of life related to Tourette's disease in children.
Read the 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, 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.
- Conditions
- Tourette's Syndrome
- Being tested
- PS128
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS128Dietary supplement
Also called Placebo
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
| Study group | Role | What they receive |
|---|---|---|
| PS128 | Experimental | Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks. Receives: Dietary Supplement: PS128 |
| Placebo | Placebo comparator | Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks. Receives: Dietary Supplement: PS128 |
| Healthy Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to 4, 8, and 12 Weeks Assessed
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline to 4, 8 and 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.
Measured: From Baseline to 12 Weeks Assessed
Clinical Global Impression Scale (CGI)
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).
Measured: From Baseline to 4, 8 and 12 Weeks Assessed
miRNA
peripheral blood miRNA expressions
Measured: From Baseline to 12 Weeks Assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start29 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette's SyndromeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805385
- Sponsor's protocol ID
- CMUH109-REC2-188
- Status last verified
- Jan 2026
- First submitted
- 17 Mar 2021
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome
- ClinicalTrials.gov ID
- NCT04805385
- Acronym / sponsor ID
- CMUH109-REC2-188
- Conditions
- Tourette's Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PS128 | Experimental | Dietary Supplement: PS128Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PS128Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks. |
| Healthy Control | No intervention | – |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS128Also: PlaceboEach 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 | Dietary supplement | PS128, Placebo |
Primary outcome
Yale Global Tic Severity Scale (YGTSS)
Time frame: 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.
9 secondary outcomes
Beck Youth Inventories (BYI-II)
Time frame: From Baseline to 12 Weeks Assessed
Attention-Deficit/Hyperactivity Disorder Test (ADHDT)
Time frame: From Baseline to 12 Weeks Assessed
Child Behavior Checklist (CBCL)
Time frame: From Baseline to 12 Weeks Assessed
Autism Behavior Checklist-Taiwan Version (ABCT)
Time frame: From Baseline to 12 Weeks Assessed
Visual Analogue Scale for GI symptoms (VAS-GI)
Time frame: From Baseline to 12 Weeks Assessed
Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL)
Time frame: From Baseline to 4, 8 and 12 Weeks Assessed
Gut microbiota
Time frame: From Baseline to 12 Weeks Assessed
Clinical Global Impression Scale (CGI)
Time frame: From Baseline to 4, 8 and 12 Weeks Assessed
miRNA
Time frame: From Baseline to 12 Weeks Assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Tourette's Syndrome
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS128 in people with Tourette's Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scale (YGTSS) (time frame: From Baseline to 4, 8, and 12 Weeks Assessed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.