Status:
UNKNOWN
The Role of Probiotics PS128 in Movement Disorders
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Rett Syndrome
Tourette Syndrome
Eligibility:
All Genders
1-50 years
Phase:
NA
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 rep...
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, behavi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03259971
Start Date
August 25 2017
End Date
August 20 2021
Last Update
October 22 2020
Active Locations (1)
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1
National Taiwan University Children Hospital
Taipei, Taiwan, 100