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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS128 | Experimental | Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg |
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| placebo | Placebo Comparator | The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PS128 | Dietary Supplement | daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| 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. | 12 weeks |
| TUG | Observe the patient's postural stability, gait, stride length, sway and test cut-off times. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Post-12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Professor Lu Neurological Clinic | Recruiting | Taoyuan City | Guishan Dist. | 333 | Taiwan |
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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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120 Participants are assigned to the PS128 and a placebo group, under the double-blind trial.
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| placebo | Dietary Supplement | daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose |
|
| 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. | Baseline and Post-12 weeks |
| 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. | Baseline and Post-12 weeks |
| 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). | Baseline and Post-12 weeks |
| 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." | Post-12 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |