The Role of Probiotics PS128 in Movement Disorders

Tourette Syndrome Clinical Trial

Official title:

The Role of Probiotics PS128 in Movement Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259971
• Other study ID #: 201703061MIPA
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2017
• Est. completion date: August 20, 2021

Study information

• Verified date: April 2020
• Source: National Taiwan University Hospital
• Contact: Wang-Tso Lee, MD,PhD
• Phone: +886-223123456
• Email: leeped[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorders
• Rett Syndrome
• Syndrome
• Tic Disorders
• Tourette Syndrome

Intervention

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
• Placebo
placebo , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome

Locations

Country	Name	City	State
Taiwan	National Taiwan University Children Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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