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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS128 | Experimental | daily ingestion of Lactobacillus plantarum PS128 capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score | 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. | Baseline to Week 12 assessed on Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin-Song Lu, MD | Professor Lu Neurological Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Professor Lu Neurological Clinic | Taoyuan City | Guishan Dist. | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34277679 | Derived | 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. |
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Participants aged between 40 to 80 who were diagnosed with idiopathic Parkinson's Disease with daily off periods more than 3 hours were enrolled from June 2019 to June 2020. All the participants were administered two capsules containing PS128 (30 billion colony-forming units per capsule) daily for 12 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | PS128 | daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Parkinson's disease patients between ages of 40-80 years old, 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | PS128 | daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed the 12-week intervention were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 assessed on medication |
|
12 weeks
For safety assessment, physical and neurological examinations were performed to evaluate the overall health of the subjects at weeks 0 and 12. In addition, all subjects were actively monitored for the occurrence of adverse events by telephone at least once per week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PS128 | daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Lu | Professor Lu Neurological Clinic | +886-3-396-0388 | lucs.clinic@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 31, 2021 | Dec 22, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 31, 2021 | Dec 22, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self |
| Change in The Parkinson's Disease Questionnaire (PDQ-39) |
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." |
| Baseline to Week 12 assessed on Medication |
| Patient Global Impression of Change (PGI-C) | 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. We exploratorily investigate participants' subjective impression after intervention by PGI-C. The percentage of participant's response in each category, such as "very much improved", "minimally improved", "no change", or "minimally worse" were used to draw an overall conclusion of the intervention potential in the open-arm trial. | Week 12 assessed on Medication |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age at onset | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | 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. | Participants who completed the 12-week intervention were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 assessed off medications |
|
|
|
|
| Primary | 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. | Participants who completed the 12-week intervention were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 assessed on medications |
|
|
|
|
| Primary | 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. | Participants who completed the 12-week intervention were analyzed. | Posted | Mean | Standard Deviation | hours | Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self |
|
|
|
|
| Primary | 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. | Participants who completed the 12-week intervention were analyzed. | Posted | Mean | Standard Deviation | hours | Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self |
|
|
|
|
| Secondary | Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score | 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. | Participants who completed the 12-week intervention were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 assessed on Medication |
|
|
|
|
| Secondary | Change in The Parkinson's Disease Questionnaire (PDQ-39) | 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." | Participants who completed the 12-week intervention were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 assessed on Medication |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGI-C) | 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. We exploratorily investigate participants' subjective impression after intervention by PGI-C. The percentage of participant's response in each category, such as "very much improved", "minimally improved", "no change", or "minimally worse" were used to draw an overall conclusion of the intervention potential in the open-arm trial. | Participants who completed the 12-week intervention were included. | Posted | Count of Participants | Participants | Week 12 assessed on Medication |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| No change |
|
| Minimally worse |
|