Clostridium Butyricum MiyairiNCT06548256
The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease
A study testing Miyarisan-BM (Clostridium Butyricum Miyairi) in people with Clostridium Butyricum Miyairi and Parkinson Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Clostridium Butyricum Miyairi, Parkinson Disease
- What is being tested?
- Miyarisan-BM (Clostridium Butyricum Miyairi)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 20 years old, diagnosed with Parkinson's disease.
Who cannot join
- People with Parkinson's disease Dementia, or Lactose Intolerance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical Univeristy Hospital
Kaohsiung City
Yang-Pei Chang, M.D.; MSc,, 886-7-2911101 ext. 8913, cyp905@gmail.com
About this study
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
Read the 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.
- Conditions
- Clostridium Butyricum Miyairi, Parkinson Disease
- Being tested
- Miyarisan-BM (Clostridium Butyricum Miyairi)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miyarisan-BM (Clostridium Butyricum Miyairi)Drug
probiotics
| Study group | Role | What they receive |
|---|---|---|
| Miyarisan-BM (Clostridium Butyricum Miyairi) first | Experimental | Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year Receives: Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) |
| Miyarisan-BM (Clostridium Butyricum Miyairi) later | Experimental | observation for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year. Receives: Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 0, 3, 12, 15, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start31 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Butyricum MiyairiStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548256
- Sponsor's protocol ID
- KMUHIRB-F(I)-20220001
- Status last verified
- Jan 2024
- First submitted
- 16 May 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06548256
- Acronym / sponsor ID
- KMUHIRB-F(I)-20220001
- Conditions
- Clostridium Butyricum Miyairi, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Miyarisan-BM (Clostridium Butyricum Miyairi) first | Experimental | Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year |
| Miyarisan-BM (Clostridium Butyricum Miyairi) later | Experimental | Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)observation for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female over 20 years old, diagnosed with Parkinson's disease.
Key exclusion criteria (1 listed)
- People with Parkinson's disease Dementia, or Lactose Intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miyarisan-BM (Clostridium Butyricum Miyairi)probiotics | Drug | Miyarisan-BM (Clostridium Butyricum Miyairi) first, Miyarisan-BM (Clostridium Butyricum Miyairi) later |
Primary outcome
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miyarisan-BM (Clostridium Butyricum Miyairi) in people with Clostridium Butyricum Miyairi and Parkinson Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang-Pei Chang, M.D.; MSc. (886-7-2911101 ext. 8913, cyp905@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 (time frame: 0, 3, 12, 15, 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.