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The Role of Probiotics PS128 in Movement Disorders

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ClinicalTrials.gov Identifier: NCT03259971
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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 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.

Condition or disease Intervention/treatment Phase
Rett Syndrome Tourette Syndrome Tic Disorders Dietary Supplement: Probiotic-Lactobacillus plantarum PS128 Dietary Supplement: Placebo Not Applicable

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, 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 8 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomized double blind placebo-controlled
Primary Purpose: Treatment
Official Title: The Role of Probiotics PS128 in Movement Disorders
Actual Study Start Date : August 25, 2017
Estimated Primary Completion Date : August 20, 2020
Estimated Study Completion Date : August 20, 2021


Arm Intervention/treatment
Placebo Comparator: Placebo (for tic disorder)
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.
Dietary Supplement: Placebo
placebo , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome

Active Comparator: PS128 (tic disorder)
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.
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
Other Name: Lactobacillus plantarum PS128

Placebo Comparator: Placebo (for Rett syndrome)
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
Dietary Supplement: Placebo
placebo , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome

Active Comparator: PS128 (Rett syndrome)
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.
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
Other Name: Lactobacillus plantarum PS128




Primary Outcome Measures :
  1. Neuropsychological test (Mullen Scales of Early Learning) [ Time Frame: Change at four months from baseline ]
    for Rett syndrome

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


Secondary Outcome Measures :
  1. RTT severity score [ Time Frame: Change at four months from baseline ]
    For Rett syndrome

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

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

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

  5. Vineland Adaptive Behavioral scale [ Time Frame: Change at four months from baseline ]
    For Rett syndrome

  6. Early social communication scales [ Time Frame: Change at four months from baseline ]
    For Rett syndrome

  7. Pediatric Evaluation of Disability Inventory [ Time Frame: Change at four months from baseline ]
    For Rett syndrome

  8. Stool and gut microbiota evaluation [ Time Frame: Change at four months from baseline ]
    For Rett and Tic disorders

  9. Child Behavior Checklist (CBCL) [ Time Frame: Change at 2 months from baseline ]
    For Tic disorders

  10. Continuous performance test [ Time Frame: Change at 2 months from baseline ]
    For Tic disorders

  11. The Migraine Disability Assessment Test [ Time Frame: Change at 2 months from baseline ]
    For Tic disorders

  12. Children's Depression Inventory [ Time Frame: Change at 2 months from baseline ]
    For Tic disorders

  13. Obsessive-compulsive inventory [ Time Frame: Change at 2 months from baseline ]
    For Tic disorders

  14. Swanson, Nolan and Pehlam version IV [ Time Frame: Change at 2 months from baseline ]
    For Tic disorders



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259971


Contacts
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Contact: Wang-Tso Lee, MD,PhD +886-223123456 ext 71618 leeped@hotmail.com
Contact: Lee Chin Wong, MD +886-223123456 ext 71618 leechinx@hotmail.com

Locations
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Taiwan
National Taiwan University Children Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wang-Tso Lee, PhD    02-23123456 ext 71618    leeped@hotmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wang-Tso Lee, MD,PhD National Taiwan University Children Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03259971    
Other Study ID Numbers: 201703061MIPA
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Rett syndrome
Tourette syndrome
Probiotic
Additional relevant MeSH terms:
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Tourette Syndrome
Movement Disorders
Rett Syndrome
Tic Disorders
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Genetic Diseases, X-Linked