The Role of Probiotics PS128 in Movement Disorders

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03259971
• Date of registration: 16/08/2017
• Prospective Registration: Yes
• Primary sponsor: National Taiwan University Hospital
• Public title: The Role of Probiotics PS128 in Movement Disorders
• Scientific title: The Role of Probiotics PS128 in Movement Disorders
• Date of first enrolment: August 25, 2017
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03259971
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Wang-Tso Lee, MD,PhD
• Affiliation: National Taiwan University Children Hospital

• Name: Wang-Tso Lee, MD,PhD

• Name: Wang-Tso Lee, PhD

Key inclusion & exclusion criteria

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



Age minimum: 1 Year
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tic Disorders

Tourette Syndrome

Rett Syndrome

Intervention(s)

Dietary Supplement: Probiotic-Lactobacillus plantarum PS128

Dietary Supplement: Placebo

Primary Outcome(s)

Neuropsychological test (Mullen Scales of Early Learning) [Time Frame: Change at four months from baseline]

Yale Global Tic Severity Scale (YGTSS) [Time Frame: Change at 2 months from baseline]

Secondary Outcome(s)

Children's Depression Inventory [Time Frame: Change at 2 months from baseline]

Early social communication scales [Time Frame: Change at four months from baseline]

Swanson, Nolan and Pehlam version IV [Time Frame: Change at 2 months from baseline]

Dystonia status (Fahn Marsden rating scale/Unified Dystonia Rating Scale ) [Time Frame: Visit 1, Visit 2, Visit 3, Visit 4 (Up to 4 months)]

Child Behavior Checklist (CBCL) [Time Frame: Change at 2 months from baseline]

Continuous performance test [Time Frame: Change at 2 months from baseline]

Ghuman-Folstein Screen for Social Interaction (SSI) [Time Frame: Change at four months from baseline]

Obsessive-compulsive inventory [Time Frame: Change at 2 months from baseline]

Stool and gut microbiota evaluation [Time Frame: Change at four months from baseline]

RTT severity score [Time Frame: Change at four months from baseline]

The Migraine Disability Assessment Test [Time Frame: Change at 2 months from baseline]

Vineland Adaptive Behavioral scale [Time Frame: Change at four months from baseline]

Anxiety, Depression, and Mood Scale (ADAMS) [Time Frame: Change at four months from baseline]

Pediatric Evaluation of Disability Inventory [Time Frame: Change at four months from baseline]

Secondary ID(s)

201703061MIPA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors