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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
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
placebo , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome
National Taiwan University Children Hospital
Taipei, Taiwan
RECRUITINGNeuropsychological test (Mullen Scales of Early Learning)
for Rett syndrome
Time frame: Change at four months from baseline
Yale Global Tic Severity Scale (YGTSS)
for Tic disorders
Time frame: Change at 2 months from baseline
RTT severity score
For Rett syndrome
Time frame: Change at four months from baseline
Dystonia status (Fahn Marsden rating scale/Unified Dystonia Rating Scale )
For Rett syndrome
Time frame: Visit 1, Visit 2, Visit 3, Visit 4 (Up to 4 months)
Anxiety, Depression, and Mood Scale (ADAMS)
For Rett syndrome
Time frame: Change at four months from baseline
Ghuman-Folstein Screen for Social Interaction (SSI)
For Rett syndrome
Time frame: Change at four months from baseline
Vineland Adaptive Behavioral scale
For Rett syndrome
Time frame: Change at four months from baseline
Early social communication scales
For Rett syndrome
Time frame: Change at four months from baseline
Pediatric Evaluation of Disability Inventory
For Rett syndrome
Time frame: Change at four months from baseline
Stool and gut microbiota evaluation
For Rett and Tic disorders
Time frame: Change at four months from baseline
Child Behavior Checklist (CBCL)
For Tic disorders
Time frame: Change at 2 months from baseline
Continuous performance test
For Tic disorders
Time frame: Change at 2 months from baseline
The Migraine Disability Assessment Test
For Tic disorders
Time frame: Change at 2 months from baseline
Children's Depression Inventory
For Tic disorders
Time frame: Change at 2 months from baseline
Obsessive-compulsive inventory
For Tic disorders
Time frame: Change at 2 months from baseline
Swanson, Nolan and Pehlam version IV
For Tic disorders
Time frame: Change at 2 months from baseline
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