The Role of Probiotics PS128 in Movement Disorders

National Taiwan University

Status: Unknown

Conditions: Tourette Syndrome; Tic Disorders; Rett Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic-Lactobacillus plantarum PS128

Study type: Interventional

Funder types: Other

Identifiers

NCT03259971

201703061MIPA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 1 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 4 patient groups, including a placebo group

Placebo (for tic disorder)

Placebo Comparator group

Description:

The placebo will be dispensed to equal the volume of 1 tablet of Probiotic PS128, which is taken orally in 2 divided doses, 12 hours apart during the study period of 2 months for Tic disorders.

Treatment:

Dietary Supplement: Placebo

PS128 (tic disorder)

Active Comparator group

Description:

The Probiotic group in tic disorder will take Probiotic-Lactobacillus plantarum PS128, which contain 300mg (3x10\^10 CFU) Lactobacillus plantarum PS128 and 100mg of Microcrystalline Cellulose in each tablet. It will be taken orally in 2 divided doses, 12 hours apart during the study period of 2 months for Tic disorders.

Treatment:

Dietary Supplement: Probiotic-Lactobacillus plantarum PS128

Placebo (for Rett syndrome)

Placebo Comparator group

Description:

The placebo will be dispensed to equal the volume of 1 tablet of Probiotic PS128, which is taken orally in 2 divided doses, 12 hours apart during the study period of 4 months for Rett syndrome

Treatment:

Dietary Supplement: Placebo

PS128 (Rett syndrome)

Active Comparator group

Description:

The Probiotic group will take Probiotic-Lactobacillus plantarum PS128, which contain 300mg (3x10\^10 CFU) Lactobacillus plantarum PS128 and 100mg of Microcrystalline Cellulose in each tablet. It will be taken orally in 2 divided doses, 12 hours apart during the study period of 4 months for Rett Syndrome.

Treatment:

Dietary Supplement: Probiotic-Lactobacillus plantarum PS128