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Status unknownNCT03259971Updated Oct 22, 2020

The Role of Probiotics PS128 in Movement Disorders

An interventional study of Probiotic-Lactobacillus plantarum PS128 and Placebo in Rett Syndrome, Tourette Syndrome and Tic Disorders, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 1 Year to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
1 Year to 50 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Rett Syndrome
  • Tourette Syndrome
  • Tic Disorders

Keywords

  • Rett syndrome
  • Tourette syndrome
  • Probiotic
03

In context

Rett Syndrome

96 studies on the registry are indexed under Rett Syndrome; 19 are open to participants now.

This study's planned enrollment of 500 is above the median of 30 across 64 interventional studies indexed under Rett Syndrome.

Browse Rett Syndrome studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Browse National Taiwan University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementProbiotic-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

    Also known as: Lactobacillus plantarum PS128

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. Neuropsychological test (Mullen Scales of Early Learning)

    for Rett syndrome

    Time frame: Change at four months from baseline

  2. Yale Global Tic Severity Scale (YGTSS)

    for Tic disorders

    Time frame: Change at 2 months from baseline

Secondary outcomes

  1. RTT severity score

    For Rett syndrome

    Time frame: Change at four months from baseline

  2. Dystonia status (Fahn Marsden rating scale/Unified Dystonia Rating Scale )

    For Rett syndrome

    Time frame: Visit 1, Visit 2, Visit 3, Visit 4 (Up to 4 months)

  3. Anxiety, Depression, and Mood Scale (ADAMS)

    For Rett syndrome

    Time frame: Change at four months from baseline

  4. Ghuman-Folstein Screen for Social Interaction (SSI)

    For Rett syndrome

    Time frame: Change at four months from baseline

  5. Vineland Adaptive Behavioral scale

    For Rett syndrome

    Time frame: Change at four months from baseline

  6. Early social communication scales

    For Rett syndrome

    Time frame: Change at four months from baseline

  7. Pediatric Evaluation of Disability Inventory

    For Rett syndrome

    Time frame: Change at four months from baseline

  8. Stool and gut microbiota evaluation

    For Rett and Tic disorders

    Time frame: Change at four months from baseline

  9. Child Behavior Checklist (CBCL)

    For Tic disorders

    Time frame: Change at 2 months from baseline

  10. Continuous performance test

    For Tic disorders

    Time frame: Change at 2 months from baseline

  11. The Migraine Disability Assessment Test

    For Tic disorders

    Time frame: Change at 2 months from baseline

  12. Children's Depression Inventory

    For Tic disorders

    Time frame: Change at 2 months from baseline

  13. Obsessive-compulsive inventory

    For Tic disorders

    Time frame: Change at 2 months from baseline

  14. Swanson, Nolan and Pehlam version IV

    For Tic disorders

    Time frame: Change at 2 months from baseline

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Children Hospital
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2017 (actual). Primary completion is estimated for Aug 2021, 47 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2017
First posted
Aug 24, 2017
StartActual
Aug 25, 2017
Primary completionEst.
Aug 20, 2021
CompletionEst.
Aug 20, 2021
Last update
Oct 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03259971
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Aug 25, 2017
Primary completion
Aug 20, 2021 (estimated)
Completion
Aug 20, 2021 (estimated)
Last update
Oct 22, 2020

Study contacts

Wang-Tso Lee, MD,PhD
Contact
leeped@hotmail.com
+886-223123456 ext. 71618
Lee Chin Wong, MD
Contact
leechinx@hotmail.com
+886-223123456 ext. 71618
Wang-Tso Lee, MD,PhD
principal investigator · National Taiwan University Children Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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