PS128 May Improve Off Duration on Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
daily ingestion of Lactobacillus plantarum PS128
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Professor Lu Neurological Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PS128
Arm Description
daily ingestion of Lactobacillus plantarum PS128 capsules
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04389762
First Posted
April 30, 2020
Last Updated
August 7, 2020
Sponsor
Professor Lu Neurological Clinic
1. Study Identification
Unique Protocol Identification Number
NCT04389762
Brief Title
PS128 May Improve Off Duration on Parkinson's Disease
Official Title
Lactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
May 13, 2020 (Actual)
Study Completion Date
June 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Professor Lu Neurological Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PS128
Arm Type
Experimental
Arm Description
daily ingestion of Lactobacillus plantarum PS128 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
daily ingestion of Lactobacillus plantarum PS128
Intervention Description
daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Primary Outcome Measure Information:
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
Baseline to Week 12 assessed on medication
Title
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII)
Description
The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms.
Time Frame
Baseline to Week 12 assessed both off and on medications
Title
Change in Patient "ON-OFF" diary recording
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.
Time Frame
Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self
Secondary Outcome Measure Information:
Title
Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score
Description
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.
Time Frame
Baseline to Week 12 assessed on Medication
Title
Change in Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
Week 12 assessed on Medication
Title
Change in The Parkinson's Disease Questionnaire (PDQ-39)
Description
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.
Time Frame
Baseline to Week 12 assessed on Medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Song Lu, MD
Organizational Affiliation
Professor Lu Neurological Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professor Lu Neurological Clinic
City
Taoyuan City
State/Province
Guishan Dist.
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34277679
Citation
Lu CS, Chang HC, Weng YH, Chen CC, Kuo YS, Tsai YC. The Add-On Effect of Lactobacillus plantarum PS128 in Patients With Parkinson's Disease: A Pilot Study. Front Nutr. 2021 Jun 30;8:650053. doi: 10.3389/fnut.2021.650053. eCollection 2021.
Results Reference
derived
Learn more about this trial
PS128 May Improve Off Duration on Parkinson's Disease
We'll reach out to this number within 24 hrs