Treat Parkinson depression with probiotics
- Trial ID
- NCT05568498
- Official Title
- Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease
- Goal
- Treat Parkinson depression with probiotics
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- University of British Columbia
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease, Depression, PARKINSON DISEASE (Disorder)
- Interventions
- Probiotic, Placebo
Summary For Families
The goal is to see whether giving a specific probiotic can ease mild to moderate depression and related mood symptoms that many people with Parkinson's experience. The approach is a daily probiotic capsule intended to shift the gut microbiome, reduce gut and systemic inflammation, and support production of neurotransmitter precursors and short-chain fatty acids that can influence mood via immune and vagal pathways, it is taken alongside your usual Parkinson's medications and is not a replacement for levodopa. The trial is enrolling people aged 40 to 80 with mild to moderate Parkinson's (Hoehn and Yahr 1,3 when ON) who have mild to moderate depression, are cognitively able (MoCA ≥21), and have not recently used probiotics or antibiotics or changed antidepressant or Parkinson's treatments.
Locations
- Pacific Parkinson's Research Centre, Vancouver, British Columbia, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Probiotic. The goal is to see whether giving a specific probiotic can ease mild to moderate depression and related mood symptoms that many people with Parkinson's experience. The approach is a daily probiotic capsule intended to shift the gut microbiome, reduce gut and systemic inflammation, and support production of neurotransmitter precursors and short-chain fatty acids that can influence mood via immune and vagal pathways, it is taken alongside your usual Parkinson's medications and is not a replacement for levodopa. The trial is enrolling people aged 40 to 80 with mild to moderate Parkinson's (Hoehn and Yahr 1,3 when ON) who have mild to moderate depression, are cognitively able (MoCA ≥21), and have not recently used probiotics or antibiotics or changed antidepressant or Parkinson's treatments.
- Who can participate?
- Participants must be between 40 Years and 80 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 Phase 2 trial is estimated to last approximately 2 years and 11 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.