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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 2 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.