Y7 for Parkinson's (NCT07619560)
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?
- 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 2 years and 3 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?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.