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Completed

NCT Number: NCT04389762

PS128 May Improve Off Duration on Parkinson's Disease

The purpose of this study is to investigate the short term effects (12 Weeks) of Lactobacillus plantarum PS128 (PS128) on Parkinson's disease (PD) symptoms.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Professor Lu Neurological Clinic

Taoyuan City, Guishan Dist., 333, Taiwan

About this study

This study is designed to examine the extent to which L. plantarum PS128 can improve symptoms in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with PD will receive PS128 treatment for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with idiopathic Parkinson's Disease
  • According to the record of ON / OFF diary for 3 consecutive days, the patient's daily off periods must be more than 3 hours a day.
  • Between ages of 40-80 years old.

Exclusion criteria

  • Patients on antibiotics within the preceding one month
  • Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
  • Have undergone surgery of liver, bladder, or gastrointestinal tract
  • Have current or history of inflammatory bowel disease
  • Have history of cancer
  • Known allergy to probiotics
  • Patients with comorbid dementia (Mini-Mental State Examination score ≤ 26) or major depression (The Beck Depression Inventory-II score ≥ 29)
  • Have received deep brain stimulation
  • Patients receiving artificial enteral or intravenous nutrition

Treatment and study plan

daily ingestion of Lactobacillus plantarum PS128

Dietary Supplement

daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)

Primary outcomes

  1. Change in Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: Baseline to Week 12 assessed on medication

    The UPDRS scores is a rating tool used to gauge the course of Parkinson's disease in patients. The minimum total score possible is 0 and the maximum total score possible is 199. Higher values represent a worse outcome.

  2. Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "OFF" Period

    Time frame: Baseline to Week 12 assessed off medications

    The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms. The minimum possible total score is 0 and the maximum possible total score is 108. Higher values represent a worse outcome.

  3. Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "ON" Period

    Time frame: Baseline to Week 12 assessed on medications

    The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms. The minimum possible total score is 0 and the maximum possible total score is 108. Higher values represent a worse outcome.

  4. Change in Patient "ON-OFF" Diary Recording "OFF" Period

    Time frame: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self

    "ON-OFF" motor fluctuations are rapid changes in mobility during which PD patients report sudden shifts from adequate mobility to mobility, usually within a few seconds or minutes. The 24-hour diary is divided into 30-minute sections and only mark one answer for each half hour period. It is to know how much time each patient spends in the different Parkinson's states. Higher hours in "OFF" period represent better outcome.

  5. Change in Patient "ON-OFF" Diary Recording "ON" Period

    Time frame: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self

    Outcome Measure Description: "ON-OFF" motor fluctuations are rapid changes in mobility during which PD patients report sudden shifts from adequate mobility to mobility, usually within a few seconds or minutes. The 24-hour diary is divided into 30-minute sections and only mark one answer for each half hour period. It is to know how much time each patient spends in the different Parkinson's states. Higher hours in "ON" period represent worse outcome.

Secondary outcomes

  1. Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score

    Time frame: Baseline to Week 12 assessed on Medication

    NMS-Quest is a 30-item Screening tool for non-motor symptoms of Parkinson's disease. The minimum total score possible is 0 and the maximum total score possible is 30. Higher values represent a worse outcome.

  2. Change in The Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Baseline to Week 12 assessed on Medication

    The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. The minimum possible score is 0 and the maximum possible score is 100. Higher values represent a worse outcome."

  3. Patient Global Impression of Change (PGI-C)

    Time frame: Week 12 assessed on Medication

    The Patient Global Impression of Change (PGI-C) consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome. We exploratorily investigate participants' subjective impression after intervention by PGI-C. The percentage of participant's response in each category, such as "very much improved", "minimally improved", "no change", or "minimally worse" were used to draw an overall conclusion of the intervention potential in the open-arm trial.

Sponsors and collaborators

Lead sponsor

Professor Lu Neurological Clinic

Other

Registry information

Official study title

Lactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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