Probiotic cocktail delays Parkinson progression
- Trial ID
- NCT07619560
- Official Title
- Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease - Use Preclinical Human Trials to Confirm the Impact of the Optimal "Probiotic Y7, Tryptophan and Branched-chain Amino Acid" Cocktail Formula on Early Stage Parkinson's Disease Patient
- Goal
- Probiotic cocktail delays Parkinson progression
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Taipei Medical University
- Study Type
- INTERVENTIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson Disease (PD), Gut Microbiota, Probiotic
- Interventions
- Y7, Placebo
Summary For Families
The trial aims to slow early Parkinson's progression by reshaping the gut microbiome and related metabolites that may influence brain inflammation and dopamine pathways. Participants take a 12-week oral Y7 probiotic cocktail with added tryptophan and branched-chain amino acids, which is designed to boost beneficial gut bacteria and change amino acid levels that can affect neurotransmitter production and inflammation; because aromatic amino acids and BCAAs can compete with levodopa for absorption and transport, the study will watch for any changes in people’s medication response. Enrollment is open to adults 30 to 85 years old with early-stage PD (Hoehn and Yahr 1-3), MRI-confirmed striatal degeneration, who respond to Parkinson’s medications, are free of major acute illnesses or certain gut infections, not pregnant or breastfeeding, and able to complete the 12-week protocol.
Locations
- Taipei Medical University Hospital, Taipei, Taiwan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Y7. The trial aims to slow early Parkinson's progression by reshaping the gut microbiome and related metabolites that may influence brain inflammation and dopamine pathways. Participants take a 12-week oral Y7 probiotic cocktail with added tryptophan and branched-chain amino acids, which is designed to boost beneficial gut bacteria and change amino acid levels that can affect neurotransmitter production and inflammation; because aromatic amino acids and BCAAs can compete with levodopa for absorption and transport, the study will watch for any changes in people’s medication response. Enrollment is open to adults 30 to 85 years old with early-stage PD (Hoehn and Yahr 1-3), MRI-confirmed striatal degeneration, who respond to Parkinson’s medications, are free of major acute illnesses or certain gut infections, not pregnant or breastfeeding, and able to complete the 12-week protocol.
- Who can participate?
- Participants must be between 30 Years and 85 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 2 years and 3 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.