Probiotic for Parkinson's (NCT05568498)
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.
- 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.
- How many visits does this trial involve?
- Two in-person visits (a first visit and a final visit) over a 12-week intervention period.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Blood draw (minimally invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.