Clinical trial NCT04805385: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tourette's Syndrome
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2021-03-18
Enrollment: 121
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: From Baseline to 4, 8, and 12 Weeks Assessed
Secondary outcomes:
measure: Beck Youth Inventories (BYI-II)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Attention-Deficit/Hyperactivity Disorder Test (ADHDT)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Child Behavior Checklist (CBCL)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Autism Behavior Checklist-Taiwan Version (ABCT)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Visual Analogue Scale for GI symptoms (VAS-GI)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL)
timeFrame: From Baseline to 4, 8 and 12 Weeks Assessed
measure: Gut microbiota
timeFrame: From Baseline to 12 Weeks Assessed
measure: Clinical Global Impression Scale (CGI)
timeFrame: From Baseline to 4, 8 and 12 Weeks Assessed
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: