PS128 May Improve Off Duration on Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Dietary Supplement: daily ingestion of Lactobacillus plantarum PS128

• Registration Number: NCT04389762
• Lead Sponsor: Professor Lu Neurological Clinic

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.

Study Timeline

• Study Start: 2019-06-04
• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-05-11
• Primary Completion: 2020-05-13
• Study First Posted: 2020-05-15
• Study Completion: 2020-06-13
• Results First Submitted: 2024-11-06
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Results First Posted: 2025-06-25
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PS128	daily ingestion of Lactobacillus plantarum PS128	daily ingestion of Lactobacillus plantarum PS128 capsules

Primary Outcome Measures

Name	Time	Method
Change in Unified Parkinson's Disease Rating Scale (UPDRS)	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.
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "OFF" Period	Baseline to Week 12 assessed off medications	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.
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "ON" Period	Baseline to Week 12 assessed on medications	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.
Change in Patient "ON-OFF" Diary Recording "OFF" Period	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. Higher hours in "OFF" period represent better outcome.
Change in Patient "ON-OFF" Diary Recording "ON" Period	Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self	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.

Secondary Outcome Measures

Name	Time	Method
Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score	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.
Patient Global Impression of Change (PGI-C)	Week 12 assessed on Medication	The Patient Global Impression of Change (PGI-C) 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)	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. The minimum possible score is 0 and the maximum possible score is 100. Higher values represent a worse outcome."

Trial Locations

Locations (1)

Professor Lu Neurological Clinic; 🇨🇳 Taoyuan City, Guishan Dist., Taiwan