The Role of Probiotics PS128 in Movement Disorders

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03259971

Collaborator

(none)

500

Enrollment

Location

Arms

47.8

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rett Syndrome Tourette Syndrome Tic Disorders	Dietary Supplement: Probiotic-Lactobacillus plantarum PS128 Dietary Supplement: Placebo	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Randomized double blind placebo-controlled

Primary Purpose:

Treatment

Official Title:

The Role of Probiotics PS128 in Movement Disorders

Actual Study Start Date :

Aug 25, 2017

Anticipated Primary Completion Date :

Aug 20, 2021

Anticipated Study Completion Date :

Aug 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo (for tic disorder) 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.	Dietary Supplement: Placebo placebo , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome
Active Comparator: PS128 (tic disorder) 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.	Dietary Supplement: Probiotic-Lactobacillus plantarum PS128 Probiotic supplement of Lactobacillus plantarum PS128 , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome Other Names: Lactobacillus plantarum PS128
Placebo Comparator: Placebo (for Rett syndrome) 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	Dietary Supplement: Placebo placebo , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome
Active Comparator: PS128 (Rett syndrome) 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.	Dietary Supplement: Probiotic-Lactobacillus plantarum PS128 Probiotic supplement of Lactobacillus plantarum PS128 , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome Other Names: Lactobacillus plantarum PS128

Outcome Measures

Primary Outcome Measures

Neuropsychological test (Mullen Scales of Early Learning) [Change at four months from baseline]
for Rett syndrome
Yale Global Tic Severity Scale (YGTSS) [Change at 2 months from baseline]
for Tic disorders

Secondary Outcome Measures

RTT severity score [Change at four months from baseline]
For Rett syndrome
Dystonia status (Fahn Marsden rating scale/Unified Dystonia Rating Scale ) [Visit 1, Visit 2, Visit 3, Visit 4 (Up to 4 months)]
For Rett syndrome
Anxiety, Depression, and Mood Scale (ADAMS) [Change at four months from baseline]
For Rett syndrome
Ghuman-Folstein Screen for Social Interaction (SSI) [Change at four months from baseline]
For Rett syndrome
Vineland Adaptive Behavioral scale [Change at four months from baseline]
For Rett syndrome
Early social communication scales [Change at four months from baseline]
For Rett syndrome
Pediatric Evaluation of Disability Inventory [Change at four months from baseline]
For Rett syndrome
Stool and gut microbiota evaluation [Change at four months from baseline]
For Rett and Tic disorders
Child Behavior Checklist (CBCL) [Change at 2 months from baseline]
For Tic disorders
Continuous performance test [Change at 2 months from baseline]
For Tic disorders
The Migraine Disability Assessment Test [Change at 2 months from baseline]
For Tic disorders
Children's Depression Inventory [Change at 2 months from baseline]
For Tic disorders
Obsessive-compulsive inventory [Change at 2 months from baseline]
For Tic disorders
Swanson, Nolan and Pehlam version IV [Change at 2 months from baseline]
For Tic disorders

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 50 Years

Sexes Eligible for Study:

All

Accepts 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