Clostridium Butyricum Miyairi, Parkinson Disease
Conditions
Brief summary
This is an open-label, single-center, non-randomized study to assess the efficacy of Clostridium Butyricum Miyairi on the motor and non-motor symptoms of Parkinson's disease
Detailed description
The physician will explain the trial procedures in the outpatient, and then obtain the written informed consent to start the interview. And randomly divided into experimental and observation groups, and according to the timing of taking Miyarisan, scale evaluation and sample collection.
Interventions
probiotics
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year Drug: observed for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Male or female over 20 years old, diagnosed with Parkinson's disease.
Exclusion criteria
* People with Parkinson's disease Dementia, or Lactose Intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 | 0, 3, 12, 15, 24 months | Part 3 of this scale assesses motor performance in 33 items. Each item is scored on a scale of 0 (normal) to 4 (severe), with a total score range of 0 to 132, and higher scores mean the patient's situation is worse. |
| Hamilton Depression Rating Scale (HAM-D) | 0, 3, 12, 15, 24 months | This scale assesses non-motor symptoms in 17 items, the total scale value is 50 (Scores 0 to 7 mean normal, 8 to 13 mean mild depression, 14 to 18 mean moderate depression, 19 to 22 mean severe depression, and ≥23 mean very severe depression). |
| Hamilton Anxiety Scale (HAM-A) | 0, 3, 12, 15, 24 months | This scale assesses non-motor symptoms in 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where ≤17 indicates mild anxiety severity, 18-24 indicate mild to moderate anxiety severity, 25-30 indicate moderate to severe anxiety severity, \>30 indicate severe anxiety. |
Countries
Taiwan
Contacts
Primary ContactYang-Pei Chang, M.D.; MSc.
Outcome results
None listed