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Effects of PS128 on Parkinsonian Symptoms

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lactobacillus plantarum PS128
Sponsored by
Professor Lu Neurological Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between ages of 40-80 years old
  • Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage between 1 and 2.5 as rated during an "on" period

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 current or history of inflammatory bowel disease
  • Have history of cancer
  • Have undergone surgery of liver, bladder, or gastrointestinal tract
  • 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) Score From Baseline to Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From 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.

Secondary Outcome Measures

Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score From 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.
Change in Patient Global Impression of Change (PGIC) Score From Baseline to Week 12 Assessed On Medication
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.

Full Information

First Posted
June 12, 2018
Last Updated
March 8, 2021
Sponsor
Professor Lu Neurological Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03566589
Brief Title
Effects of PS128 on Parkinsonian Symptoms
Official Title
Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 examine 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
30 (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)
Lactobacillus plantarum PS128
Other Intervention Name(s)
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) Score From Baseline to Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 12 Assessed On Medication
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
Secondary Outcome Measure Information:
Title
Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score From Baseline to Week 12 Assessed On Medication
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
to Week 12 Assessed On Medication
Title
Change in Patient Global Impression of Change (PGIC) Score From Baseline to Week 12 Assessed On Medication
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
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: Between ages of 40-80 years old Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage between 1 and 2.5 as rated during an "on" period 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 current or history of inflammatory bowel disease Have history of cancer Have undergone surgery of liver, bladder, or gastrointestinal tract 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
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

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Effects of PS128 on Parkinsonian Symptoms

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