PS128 May Improve Off Duration on Parkinson's Disease

NCT04389762 | Completed Results

• 1 other identifier: PS128-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• 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) "OFF" Period

  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.

  Baseline to Week 12 assessed off medications

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

  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.

  Baseline to Week 12 assessed on medications

• Change in Patient "ON-OFF" Diary Recording "OFF" Period

  "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.

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

• Change in Patient "ON-OFF" Diary Recording "ON" Period

  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.

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

Secondary Outcomes (3)

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

  Baseline to Week 12 assessed on Medication

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

  Baseline to Week 12 assessed on Medication

• Patient Global Impression of Change (PGI-C)

  Week 12 assessed on Medication

Study Arms (1)

PS128

EXPERIMENTAL

daily ingestion of Lactobacillus plantarum PS128 capsules

Dietary Supplement: daily ingestion of Lactobacillus plantarum PS128

Interventions

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)

PS128

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Lu Neurological Clinic: lead

Study Sites (1)

Professor Lu Neurological Clinic

Taoyuan, Guishan Dist., 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 34277679 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Professor Lu
• Organization: Professor Lu Neurological Clinic

lucs.clinic@gmail.com

+886-3-396-0388

Study Officials

• Chin-Song Lu, MD

  Professor Lu Neurological Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 15, 2020
• Study Start: June 4, 2019
• Primary Completion: May 13, 2020
• Study Completion: June 13, 2020
• Last Updated: August 17, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)