Probiotics reduce acting out dreams
- Trial ID
- NCT06710574
- Official Title
- Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving Rapid Eye Movement Behavior Disorder with Parkinson's Disease
- Goal
- Probiotics reduce acting out dreams
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- Beijing Friendship Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson Disease, Movement Disorders, Rapid Eye Movement Sleep Behavior Disorder, Gut Microbiomes, Magnetic Resonance Imaging (MRI), Probiotic
- Interventions
- PD-RBD, iRBD
Summary For Families
The goal is to test whether taking specific probiotics can ease REM sleep behavior disorder symptoms in people with Parkinson's and in those with idiopathic RBD, and to learn how changing gut microbes might influence the brain. The approach gives probiotics containing Bifidobacterium triple viable and Bacillus licheniformis to shift the gut microbiome, which may reduce gut-driven inflammation and alter gut‑to‑brain signaling; researchers will track sleep and brain changes with polysomnography and MRI, and participants keep their Parkinson's meds stable since the probiotic is not a replacement for levodopa. They are looking for adults roughly 40 to 85 years old, including people with Parkinson's (Hoehn and Yahr stage 1,3) who have RBD, people with idiopathic RBD, and healthy controls, all with normal cognition, no recent probiotic or antibiotic use, and off clonazepam or melatonin before joining.
Locations
- Beijing Friendship Hospital, Capital Medical University, Beijing, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying PD-RBD. The goal is to test whether taking specific probiotics can ease REM sleep behavior disorder symptoms in people with Parkinson's and in those with idiopathic RBD, and to learn how changing gut microbes might influence the brain. The approach gives probiotics containing Bifidobacterium triple viable and Bacillus licheniformis to shift the gut microbiome, which may reduce gut-driven inflammation and alter gut‑to‑brain signaling; researchers will track sleep and brain changes with polysomnography and MRI, and participants keep their Parkinson's meds stable since the probiotic is not a replacement for levodopa. They are looking for adults roughly 40 to 85 years old, including people with Parkinson's (Hoehn and Yahr stage 1,3) who have RBD, people with idiopathic RBD, and healthy controls, all with normal cognition, no recent probiotic or antibiotic use, and off clonazepam or melatonin before joining.
- Who can participate?
- Participants must be between 40 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 Phase 4 trial is estimated to last approximately 2 years and 9 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.