PS128 May Improve Off Duration on Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: daily ingestion of Lactobacillus plantarum PS128


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PS128<br>daily ingestion of Lactobacillus plantarum PS128 capsules | Dietary Supplement: daily ingestion of Lactobacillus plantarum PS128<br>* daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) | 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. | Baseline to Week 12 assessed on medication | 
| Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) | The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms. | Baseline to Week 12 assessed both off and on medications | 
| Change in Patient ON-OFF diary recording | 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. | Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score | 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. | Baseline to Week 12 assessed on Medication | 
| Change in Patient Global Impression of Change (PGIC) | The PGIC 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. | Week 12 assessed on Medication | 
| Change in The Parkinson's Disease Questionnaire (PDQ-39) | 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. | Baseline to Week 12 assessed on Medication |