- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04722211
Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guishan Dist.
-
Taoyuan City, Guishan Dist., Taiwan, 333
- Recruiting
- Professor Lu Neurological Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PS128
Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg
|
daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule)
|
Placebo Comparator: placebo
The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose
|
daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UPDRS III
Time Frame: 12 weeks
|
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. |
12 weeks
|
MHY
Time Frame: 12 weeks
|
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. |
12 weeks
|
TUG
Time Frame: 12 weeks
|
Observe the patient's postural stability, gait, stride length, sway and test cut-off times.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UPDRS I-IV
Time Frame: Baseline and Post-12 weeks
|
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. |
Baseline and Post-12 weeks
|
SCL-90-R
Time Frame: Baseline and Post-12 weeks
|
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. |
Baseline and Post-12 weeks
|
CPSQI
Time Frame: Baseline and Post-12 weeks
|
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.
|
Baseline and Post-12 weeks
|
VAS-GI
Time Frame: Baseline and Post-12 weeks
|
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).
|
Baseline and Post-12 weeks
|
PGIC
Time Frame: Post-12 weeks
|
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."
|
Post-12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS128-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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