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

China Medical University

Status: Completed

Conditions: Tourette's Syndrome

Treatments: Dietary Supplement: PS128

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04805385

CMUH109-REC2-188

Details and patient eligibility

About

To evaluate whether supplementing with PS128 can improve the symptoms and quality of life related to Tourette's disease in children.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 3 patient groups, including a placebo group

PS128

Experimental group

Description:

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

Treatment:

Dietary Supplement: PS128

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: PS128

Healthy Control

No Intervention group