Miyarisan-BM for Parkinson's (NCT06548256)
Reduce motor and nonmotor symptoms
- Trial ID
- NCT06548256
- Official Title
- The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease
- Goal
- Reduce motor and nonmotor symptoms
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 400 participants
- Conditions
- Clostridium Butyricum Miyairi, Parkinson Disease
- Interventions
- Miyarisan-BM (Clostridium Butyricum Miyairi)
Summary For Families
The trial is testing whether the probiotic Clostridium butyricum Miyairisan can help improve motor and non-motor Parkinson's symptoms, especially gut-related problems that can worsen medication response. Miyarisan-BM is a live probiotic that produces butyrate and helps rebalance the gut microbiome, which may reduce intestinal inflammation, ease constipation, strengthen the gut barrier, and indirectly affect how levodopa is absorbed and how well motor symptoms are controlled. People aged 20 to 90 with Parkinson's disease can join, but those with Parkinson's disease dementia or lactose intolerance are excluded.
Locations
- Kaohsiung Medical Univeristy Hospital, Kaohsiung City, Taiwan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Miyarisan-BM (Clostridium Butyricum Miyairi). The trial is testing whether the probiotic Clostridium butyricum Miyairisan can help improve motor and non-motor Parkinson's symptoms, especially gut-related problems that can worsen medication response. Miyarisan-BM is a live probiotic that produces butyrate and helps rebalance the gut microbiome, which may reduce intestinal inflammation, ease constipation, strengthen the gut barrier, and indirectly affect how levodopa is absorbed and how well motor symptoms are controlled. People aged 20 to 90 with Parkinson's disease can join, but those with Parkinson's disease dementia or lactose intolerance are excluded.
- Who can participate?
- Participants must be between 20 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.