The Role of Probiotics PS128 in Movement Disorders
- Conditions
- Rett SyndromeTourette SyndromeTic Disorders
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Probiotic-Lactobacillus plantarum PS128
- Registration Number
- NCT03259971
- Lead Sponsor
- National Taiwan University Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (for tic disorder) Placebo 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. Placebo (for Rett syndrome) Placebo 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 PS128 (Rett syndrome) Probiotic-Lactobacillus plantarum PS128 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. PS128 (tic disorder) Probiotic-Lactobacillus plantarum PS128 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Children's Depression Inventory Change at 2 months from baseline For Tic disorders
RTT severity score Change at four months from baseline For Rett syndrome
Anxiety, Depression, and Mood Scale (ADAMS) Change at four months from baseline For Rett syndrome
Early social communication scales Change at four months from baseline For Rett syndrome
The Migraine Disability Assessment Test Change at 2 months from baseline For Tic disorders
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
Vineland Adaptive Behavioral scale 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
Obsessive-compulsive inventory Change at 2 months from baseline For Tic disorders
Ghuman-Folstein Screen for Social Interaction (SSI) Change at four months from baseline For Rett syndrome
Swanson, Nolan and Pehlam version IV Change at 2 months from baseline For Tic disorders
Trial Locations
- Locations (1)
National Taiwan University Children Hospital
🇨🇳Taipei, Taiwan