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

Last updated: June 25, 2024
Sponsor: China Medical University Hospital
Overall Status: Completed

Phase

N/A

Condition

Tourette's Syndrome

Autism

Tic Disorders

Treatment

PS128

Clinical Study ID

NCT04805385
CMUH109-REC2-188
  • Ages 4-18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 byPI

Exclusion

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 (exceptyogurt, yogurt, Yakult and other related foods)

  • Patients who have undergone hepatobiliary gastrointestinal surgery (except forcolorectal 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

Study Design

Total Participants: 121
Treatment Group(s): 1
Primary Treatment: PS128
Phase:
Study Start date:
November 29, 2021
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • China Medical University Hospital

    Taichung, 404332
    Taiwan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.