Effects of PS128 on Parkinsonian Symptoms
Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease: a Pilot Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Jul 2018
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedStudy Start
First participant enrolled
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedMarch 10, 2021
March 1, 2021
4 months
June 12, 2018
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to Week 12
Secondary Outcomes (2)
Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score From Baseline to Week 12 Assessed On Medication
to Week 12 Assessed On Medication
Change in Patient Global Impression of Change (PGIC) Score From Baseline to Week 12 Assessed On Medication
to Week 12 Assessed On Medication
Study Arms (1)
PS128
EXPERIMENTALdaily ingestion of Lactobacillus plantarum PS128 capsules
Interventions
daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Eligibility Criteria
You may qualify if:
- 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
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Professor Lu Neurological Clinic
Taoyuan, Guishan Dist., 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2018
First Posted
June 25, 2018
Study Start
July 2, 2018
Primary Completion
November 9, 2018
Study Completion
December 30, 2018
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share