Back to resultsEffects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PS128
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring probiotics, parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- Modified Hoehn &Yahr stage, MHY 1-3
- 45-80 years old
- at least 9 years education
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
- Diagnosed before 40 years old
- Poor control of other chronic diseases
- Not eligible judged by PI
Sites / Locations
- Professor Lu Neurological ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PS128
placebo
Arm Description
Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg
The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose
Outcomes
Primary Outcome Measures
UPDRS III
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The PART III is Motor sections.
MHY
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.
The modified Hoehn and Yahr scale included stages 1 through 5. to help describe the intermediate course of the disease.
TUG
Observe the patient's postural stability, gait, stride length, sway and test cut-off times.
Secondary Outcome Measures
UPDRS I-IV
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.
SCL-90-R
The Symptom Checklist-90-Revised instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology.
The SCL-90-R is normed on individuals 13 years and older. It consists of 90 items and takes 12-15 minutes to administer.
CPSQI
The Chinese Version of the Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.The maximum total score is 21. A higher score reflects more poor sleep quality.
VAS-GI
Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm).
PGIC
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Full Information
NCT ID
NCT04722211
First Posted
January 15, 2021
Last Updated
January 21, 2021
Sponsor
Professor Lu Neurological Clinic
1. Study Identification
Unique Protocol Identification Number
NCT04722211
Brief Title
Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
Official Title
Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
This RCT 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 or placebo intervention for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.
Detailed Description
This RCT 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 or placebo intervention 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
Keywords
probiotics, parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
120 Participants are assigned to the PS128 and a placebo group, under the double-blind trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PS128
Arm Type
Experimental
Arm Description
Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose
Intervention Type
Dietary Supplement
Intervention Name(s)
PS128
Intervention Description
daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule)
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose
Primary Outcome Measure Information:
Title
UPDRS III
Description
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The PART III is Motor sections.
Time Frame
12 weeks
Title
MHY
Description
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.
The modified Hoehn and Yahr scale included stages 1 through 5. to help describe the intermediate course of the disease.
Time Frame
12 weeks
Title
TUG
Description
Observe the patient's postural stability, gait, stride length, sway and test cut-off times.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
UPDRS I-IV
Description
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.
Time Frame
Baseline and Post-12 weeks
Title
SCL-90-R
Description
The Symptom Checklist-90-Revised instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology.
The SCL-90-R is normed on individuals 13 years and older. It consists of 90 items and takes 12-15 minutes to administer.
Time Frame
Baseline and Post-12 weeks
Title
CPSQI
Description
The Chinese Version of the Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.The maximum total score is 21. A higher score reflects more poor sleep quality.
Time Frame
Baseline and Post-12 weeks
Title
VAS-GI
Description
Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm).
Time Frame
Baseline and Post-12 weeks
Title
PGIC
Description
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Time Frame
Post-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Modified Hoehn &Yahr stage, MHY 1-3
45-80 years old
at least 9 years education
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
Diagnosed before 40 years old
Poor control of other chronic diseases
Not eligible judged by PI
Facility Information:
Facility Name
Professor Lu Neurological Clinic
City
Taoyuan City
State/Province
Guishan Dist.
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIN-SONG LU, MD
Phone
033960388
Email
lucs.clinic@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
We'll reach out to this number within 24 hrs