Parkinson Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTdaily ingestion of Lactobacillus plantarum PS128
daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Sponsors
Professor Lu Neurological Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. 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. |
| 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. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | PS128 | — |
|---|---|---|
| Age at onset | 51.72 years STANDARD_DEVIATION 6.59 | — |
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 22 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Taiwan | 25 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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.
Time frame: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self
Population: Participants who completed the 12-week intervention were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS128 | Change in Patient ON-OFF Diary Recording OFF Period | pre | 6.52 hours | Standard Deviation 1.66 |
| PS128 | Change in Patient ON-OFF Diary Recording OFF Period | post | 5.72 hours | Standard Deviation 2.64 |
p-value: 0.04t-test, 2 sided
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.
Time frame: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self
Population: Participants who completed the 12-week intervention were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS128 | Change in Patient ON-OFF Diary Recording ON Period | pre | 9.92 hours | Standard Deviation 1.76 |
| PS128 | Change in Patient ON-OFF Diary Recording ON Period | psot | 10.76 hours | Standard Deviation 1.68 |
p-value: 0.031t-test, 2 sided
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.
Time frame: Baseline to Week 12 assessed off medications
Population: Participants who completed the 12-week intervention were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS128 | Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) OFF Period | pre | 27.16 score on a scale | Standard Deviation 7.11 |
| PS128 | Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) OFF Period | post | 24.08 score on a scale | Standard Deviation 8.2 |
p-value: 0.004t-test, 2 sided
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.
Time frame: Baseline to Week 12 assessed on medications
Population: Participants who completed the 12-week intervention were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS128 | Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) ON Period | pre | 17.56 score on a scale | Standard Deviation 6.92 |
| PS128 | Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) ON Period | post | 15.00 score on a scale | Standard Deviation 7.76 |
p-value: 0.007t-test, 2 sided
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.
Time frame: Baseline to Week 12 assessed on medication
Population: Participants who completed the 12-week intervention were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS128 | Change in Unified Parkinson's Disease Rating Scale (UPDRS) | pre | 33.00 score on a scale | Standard Deviation 10.65 |
| PS128 | Change in Unified Parkinson's Disease Rating Scale (UPDRS) | post | 29.24 score on a scale | Standard Deviation 10.26 |
p-value: 0.003t-test, 2 sided
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.
Time frame: Baseline to Week 12 assessed on Medication
Population: Participants who completed the 12-week intervention were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS128 | Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score | pre | 6.84 score on a scale | Standard Deviation 4.65 |
| PS128 | Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score | post | 6.28 score on a scale | Standard Deviation 4.35 |
p-value: 0.115t-test, 2 sided
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.
Time frame: Baseline to Week 12 assessed on Medication
Population: Participants who completed the 12-week intervention were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS128 | Change in The Parkinson's Disease Questionnaire (PDQ-39) | pre | 19.86 score on a scale | Standard Deviation 9.6 |
| PS128 | Change in The Parkinson's Disease Questionnaire (PDQ-39) | post | 14.18 score on a scale | Standard Deviation 8.61 |
p-value: 0.031t-test, 2 sided
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.
Time frame: Week 12 assessed on Medication
Population: Participants who completed the 12-week intervention were included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PS128 | Patient Global Impression of Change (PGI-C) | Very much improved | 1 Participants |
| PS128 | Patient Global Impression of Change (PGI-C) | Much improved | 4 Participants |
| PS128 | Patient Global Impression of Change (PGI-C) | Minimally improved | 12 Participants |
| PS128 | Patient Global Impression of Change (PGI-C) | No change | 7 Participants |
| PS128 | Patient Global Impression of Change (PGI-C) | Minimally worse | 1 Participants |