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

Primary Purpose

Tourette's Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PS128
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tourette's Syndrome

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

PS128

Placebo

Healthy Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Attention-Deficit/Hyperactivity Disorder Test (ADHDT)
The test yields standard scores, percentile ranks, severity levels, and probability of ADHD.
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.
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.
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.
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.
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.

Full Information

First Posted
March 17, 2021
Last Updated
November 28, 2021
Sponsor
China Medical University Hospital
Collaborators
Bened Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04805385
Brief Title
Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome
Official Title
Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
Collaborators
Bened Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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, 2022. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PS128
Arm Type
Experimental
Arm Description
Subjects will consume the PS128 capsules every day, 2 capsules at a time, for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will consume the placebo capsules every day, 2 capsules at a time, for 12 weeks.
Arm Title
Healthy Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
PS128
Other Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Yale Global Tic Severity Scale (YGTSS)
Description
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 12 Weeks Assessed
Secondary Outcome Measure Information:
Title
Beck Youth Inventories (BYI-II)
Description
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
Title
Attention-Deficit/Hyperactivity Disorder Test (ADHDT)
Description
The test yields standard scores, percentile ranks, severity levels, and probability of ADHD.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Child Behavior Checklist (CBCL)
Description
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
Title
Autism Behavior Checklist-Taiwan Version (ABCT)
Description
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
Title
Visual Analogue Scale for GI symptoms (VAS-GI)
Description
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.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL)
Description
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.
Time Frame
From Baseline to 12 Weeks Assessed
Title
Gut microbiota
Description
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.
Time Frame
From Baseline to 12 Weeks Assessed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I-Ching Chou, MD
Phone
+886 4 22052121
Ext
4641
Email
iching@mail.cmu.edu.tw
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I-Ching Chou, MD
Phone
+886 4 22052121
Ext
4641
Email
iching@mail.cmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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