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Completed

NCT Number: NCT04805385

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.

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Key information

Conditions

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

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 404332, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. Beck Youth Inventories (BYI-II)

    Time frame: From Baseline to 12 Weeks Assessed

    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.

  2. Attention-Deficit/Hyperactivity Disorder Test (ADHDT)

    Time frame: From Baseline to 12 Weeks Assessed

    The test yields standard scores, percentile ranks, severity levels, and probability of ADHD.

  3. Child Behavior Checklist (CBCL)

    Time frame: From Baseline to 12 Weeks Assessed

    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.

  4. Autism Behavior Checklist-Taiwan Version (ABCT)

    Time frame: From Baseline to 12 Weeks Assessed

    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.

  5. Visual Analogue Scale for GI symptoms (VAS-GI)

    Time frame: From Baseline to 12 Weeks Assessed

    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.

  6. Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL)

    Time frame: From Baseline to 4, 8 and 12 Weeks Assessed

    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.

  7. Gut microbiota

    Time frame: From Baseline to 12 Weeks Assessed

    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.

  8. Clinical Global Impression Scale (CGI)

    Time frame: From Baseline to 4, 8 and 12 Weeks Assessed

    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).

  9. miRNA

    Time frame: From Baseline to 12 Weeks Assessed

    peripheral blood miRNA expressions

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • Bened Biomedical Co., Ltd.

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2021
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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