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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (for tic disorder) | Placebo Comparator | 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. |
|
| PS128 (tic disorder) | Active Comparator | 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. |
|
| Placebo (for Rett syndrome) | Placebo Comparator | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic-Lactobacillus plantarum PS128 | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological test (Mullen Scales of Early Learning) | for Rett syndrome | Change at four months from baseline |
| Yale Global Tic Severity Scale (YGTSS) | for Tic disorders | Change at 2 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| RTT severity score | For Rett syndrome | Change at four months from baseline |
| Dystonia status (Fahn Marsden rating scale/Unified Dystonia Rating Scale ) | For Rett syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang-Tso Lee, MD,PhD | Contact | +886-223123456 | 71618 | leeped@hotmail.com |
| Lee Chin Wong, MD | Contact | +886-223123456 | 71618 | leechinx@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang-Tso Lee, MD,PhD | National Taiwan University Children Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Children Hospital | Recruiting | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38361371 | Derived | Wong LC, Hsu CJ, Wu YT, Chu HF, Lin JH, Wang HP, Hu SC, Tsai YC, Tsai WC, Lee WT. Investigating the impact of probiotic on neurological outcomes in Rett syndrome: A randomized, double-blind, and placebo-controlled pilot study. Autism. 2024 Sep;28(9):2267-2281. doi: 10.1177/13623613231225899. Epub 2024 Feb 15. |
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| ID | Term |
|---|---|
| D015518 | Rett Syndrome |
| D005879 | Tourette Syndrome |
| D013981 | Tic Disorders |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Randomized double blind placebo-controlled
|
| Placebo | Dietary Supplement | placebo , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome |
|
| Visit 1, Visit 2, Visit 3, Visit 4 (Up to 4 months) |
| Anxiety, Depression, and Mood Scale (ADAMS) | For Rett syndrome | Change at four months from baseline |
| Ghuman-Folstein Screen for Social Interaction (SSI) | For Rett syndrome | Change at four months from baseline |
| Vineland Adaptive Behavioral scale | For Rett syndrome | Change at four months from baseline |
| Early social communication scales | For Rett syndrome | Change at four months from baseline |
| Pediatric Evaluation of Disability Inventory | For Rett syndrome | Change at four months from baseline |
| Stool and gut microbiota evaluation | For Rett and Tic disorders | Change at four months from baseline |
| Child Behavior Checklist (CBCL) | For Tic disorders | Change at 2 months from baseline |
| Continuous performance test | For Tic disorders | Change at 2 months from baseline |
| The Migraine Disability Assessment Test | For Tic disorders | Change at 2 months from baseline |
| Children's Depression Inventory | For Tic disorders | Change at 2 months from baseline |
| Obsessive-compulsive inventory | For Tic disorders | Change at 2 months from baseline |
| Swanson, Nolan and Pehlam version IV | For Tic disorders | Change at 2 months from baseline |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D019636 | Neurodegenerative Diseases |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |