Early Onset Parkinson Disease
Conditions
Brief summary
This study is designed to examine L. plantarum PS128 can improve symptoms in early onset PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with early onset 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_SUPPLEMENTPS128
daily ingestion 2 capsules of Lactobacillus plantarum PS128 (\>10 billion CFU/capsule)
Sponsors
Professor Lu Neurological Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Early Onset Parkinson's Disease, EOPD * at least 9 years education * age between 20 and 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 * Diagnosed before 40 years old * Poor control of other chronic diseases * Not eligible judged by PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UPDRS III | 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. |
| MHY | 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. |
| TUG | 12 weeks | Observe the patient's postural stability, gait, stride length, sway and test cut-off times. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS-GI | 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). |
| UPDRS I-IV | 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. |
| PGIC | 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. |
| SCL-90-R | 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. |
| CPSQI | 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. |
Countries
Taiwan
Contacts
Primary ContactChin-Song Lu, MD
Outcome results
None listed