PS128 May Improve Off Duration on Parkinson's Disease

August 7, 2020 updated by: CHIN-SONG LU, Professor Lu Neurological Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Guishan Dist.
      • Taoyuan City, Guishan Dist., Taiwan, 333
        • Professor Lu Neurological Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PS128
daily ingestion of Lactobacillus plantarum PS128 capsules
Dietary supplement: daily ingestion of Lactobacillus plantarum PS128
daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 12 assessed on medication
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII)
Time Frame: Baseline to Week 12 assessed both off and on medications
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
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.
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
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.
Baseline to Week 12 assessed on Medication
Change in Patient Global Impression of Change (PGIC)
Time Frame: 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.
Week 12 assessed on Medication
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.
Baseline to Week 12 assessed on Medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Lu Neurological Clinic

Investigators

  • Principal Investigator: Chin-Song Lu, MD, Professor Lu Neurological Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2019

Primary Completion (Actual)

May 13, 2020

Study Completion (Actual)

June 13, 2020

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS128-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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