The Role of Probiotics PS128 in Movement Disorders

The Role of Probiotics PS128 in Movement Disorders

Pediatric movement disorders comprise of a large number of different neurological diseases including Rett syndrome (RTT) and Tourette syndrome. Studies in the literature as well as our preliminary reports showed that Rett syndrome and Tourette syndrome/Tic disorders are associated with a dysbiosis of the gut microbiota compared to normal control. Probiotic Lactobacillus plantarum PS128 is a diet supplement that available for human consumption. Probiotic Lactobacillus plantarum PS128 had showed psychotropic effects such as ameliorate anxiety- and depression-like behaviors as well as altered the level of neurotransmitters such as dopamine in the brain in animal models, which might be through microbiota-gut-brain axis. Therefore, the purpose of this study is to access the possible neurobehavior effects of Probiotic Lactobacillus plantarum PS128 in Rett syndrome and Tic disorders/Tourette syndrome.

The study is a placebo-controlled double-blind randomized study, to determine the benefits of probiotic Lactobacillus plantarum PS128 vs placebo on symptoms for Tic disorders; and the symptoms, behavior, or cognition for Rett syndrome.

Patients with the Rett syndrome and Tic disorders/Tourette syndrome will be recruited into our study.The study period will last 4 months for Rett syndrome patients, age one year-50years; while 2 months for Tic disorders/Tourette syndrome patient, age 5 years-18 years.

The study will be performed in National Taiwan University Children Hospital. The patients will have neuropsychological and gut microbiota evaluation before and at the end of the study. There will also be interim follow up evaluations each month after the patient start taking the probiotic or placebo.

Inclusion Criteria:

• Rett syndrome:
• Males and females who have classic or atypical RTT diagnosed under consensus criteria
• Age: 1-50 years
• Tic disorders:
• males and females with clinical diagnosis
• Age: 8-18years
• Treatment naive 4 weeks prior to study
• Those with standard medications, dosage stable 4 weeks prior to study
• AADC syndrome:
• Males and females with AADC diagnosis
• Age: 1-50 years

Exclusion Criteria:

• Those who took probiotic or probiotic related product 4 weeks prior to the study or during the study
• Those who took antibiotic 4 weeks prior to the study
• Those showing poor compliance with any aspect of the study
• Those had adverse reactions to PS128