An interventional study of Miyarisan-BM (Clostridium Butyricum Miyairi) in Clostridium Butyricum Miyairi and Parkinson Disease, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Treatment
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
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 400 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year
Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)
observation for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year.
Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)
probiotics
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
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.
Time frame: 0, 3, 12, 15, 24 months
Hamilton Depression Rating Scale (HAM-D)
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).
Time frame: 0, 3, 12, 15, 24 months
Hamilton Anxiety Scale (HAM-A)
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.
Time frame: 0, 3, 12, 15, 24 months
Plan to share: No
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Kaohsiung Medical University Chung-Ho Memorial Hospital