The Role of Probiotics PS128 in Movement Disorders

NCT03259971 | Unknown

• 1 other identifier: 201703061MIPA
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Rett Syndrome; Tourette Syndrome; Tic Disorders

Keywords

Rett syndrome; Tourette syndrome; Probiotic

Outcome Measures

Primary Outcomes (2)

• Neuropsychological test (Mullen Scales of Early Learning)

  for Rett syndrome

  Change at four months from baseline

• Yale Global Tic Severity Scale (YGTSS)

  for Tic disorders

  Change at 2 months from baseline

Secondary Outcomes (14)

• RTT severity score

  Change at four months from baseline

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

  Visit 1, Visit 2, Visit 3, Visit 4 (Up to 4 months)

• Anxiety, Depression, and Mood Scale (ADAMS)

  Change at four months from baseline

• Ghuman-Folstein Screen for Social Interaction (SSI)

  Change at four months from baseline

• Vineland Adaptive Behavioral scale

  Change at four months from baseline

Study Arms (4)

Placebo (for tic disorder)

PLACEBO COMPARATOR

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

PS128 (tic disorder)

ACTIVE COMPARATOR

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 (for Rett syndrome)

PLACEBO COMPARATOR

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

PS128 (Rett syndrome)

ACTIVE COMPARATOR

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

Probiotic-Lactobacillus plantarum PS128 DIETARY_SUPPLEMENT

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

PS128 (Rett syndrome); PS128 (tic disorder)

Placebo DIETARY_SUPPLEMENT

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

Placebo (for Rett syndrome); Placebo (for tic disorder)

Eligibility Criteria

• Age: 1 Year - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Children Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

• Wong LC, Hsu CJ, Wu YT, Chu HF, Lin JH, Wang HP, Hu SC, Tsai YC, Tsai WC, Lee WT. Investigating the impact of probiotic on neurological outcomes in Rett syndrome: A randomized, double-blind, and placebo-controlled pilot study. Autism. 2024 Sep;28(9):2267-2281. doi: 10.1177/13623613231225899. Epub 2024 Feb 15.

  PMID: 38361371 DERIVED

MeSH Terms

Conditions

Rett Syndrome; Tourette Syndrome; Tic Disorders

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Wang-Tso Lee, MD,PhD

  National Taiwan University Children Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang-Tso Lee, MD,PhD

CONTACT

+886-223123456; leeped@hotmail.com

Lee Chin Wong, MD

CONTACT

+886-223123456; leechinx@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized double blind placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 24, 2017
• Study Start: August 25, 2017
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)