PD-RBD for Parkinson's (NCT06710574)
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?
- 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 Phase 4 trial is estimated to last approximately 2 years and 9 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 a group that receives no study treatment (you would continue your usual care) alongside the treatment groups. Because assignment is random, you have about a 2 in 4 chance (roughly 50%) of being in the no-treatment 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: MRI scan (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- You must discontinue benzodiazepines such as clonazepam and melatonin in the month prior to enrollment, and must not have used probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment (a two-month washout period should be observed if they were used).