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New treatment option for Parkinson Disease
Official title Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease
ClinicalTrials.gov ID: NCT06710574
What this study is testing
What is PD-RBD?
PD-RBD is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Rapid eye movement sleep behavior disorder (RBD) is important non-movement feature, and also the important risk factor of Parkinson's disease (PD). In our previous work, we found that the movement features and RBD of PD patients improved after taking probiotics.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85. Healthy volunteers may be eligible.
You may be able to join if
- for PD-RBD patients:
- Age between 40 and 80 years, both males and females
- Patients with idiopathic Parkinson's disease, meeting the MDS clinical diagnostic criteria for Parkinson's disease (2015)
- Modified Hoehn and Yahr stage of Parkinson's disease ≤ stage 3
- No dementia, with a Mini-Mental State Examination (MMSE) score \> 24
You likely can't join if
- PD-RBD exclusion criteria:
- Parkinsonism plus syndrome and secondary parkinsonism such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia...
- Taking any probiotics or prebiotics (including lactulose) or antibiotics within 2 months before enrollment
- Adjustment of Parkinson's disease medication within 1 month before enrollment; In group 1 month before taking clonazepam and benzodiazepines medicine...
- With the following diseases such as Alzheimer's disease, malignant tumor, spinal cord lesions, epilepsy, autonomic nerve disease (urinary retention...
- Patients with anxiety or depression and taking medication
See the full eligibility criteria
Who can join
- for PD-RBD patients:
- Age between 40 and 80 years, both males and females
- Patients with idiopathic Parkinson's disease, meeting the MDS clinical diagnostic criteria for Parkinson's disease (2015)
- Modified Hoehn and Yahr stage of Parkinson's disease ≤ stage 3
- No dementia, with a Mini-Mental State Examination (MMSE) score \> 24
- No depression or anxiety, as indicated by Hamilton Depression Scale score \< 9 and Anxiety Scale score \< 14
- Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score \> 5, diagnosed with RBD based on polysomnography results, and exclusion of obstructive sleep apnea
- Stable condition of Parkinson's disease motor symptoms and RBD symptoms in the month prior to enrollment, with no adjustments to Parkinson's disease medications in the month prior to enrollment
- Discontinuation of benzodiazepines such as clonazepam and melatonin in the month prior to enrollment
- No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed
- Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form. for iRBD patients:
- Age between 40 and 80 years, both males and females
- Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score \> 5, diagnosed with RBD based on polysomnography results, and exclusion of obstructive sleep apnea or restless legs syndrome
- No dementia, with a Mini-Mental State Examination (MMSE) score \> 24
- No depression or anxiety, as indicated by Hamilton Depression Scale score \< 9 and Anxiety Scale score \< 14
- Discontinuation of benzodiazepines such as clonazepam and melatonin in the month prior to enrollment
- No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed
- Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form. for healthy people
- Age between 40 and 80 years, age and gender matched with the above two groups of patients
- Rapid Eye Movement Sleep Behavior Disorder screening questionnaire score ≤ 5, exclusion of RBD or obstructive sleep apnea based on polysomnography results
- No dementia, with a Mini-Mental State Examination (MMSE) score \> 24.
- No depression or anxiety, as indicated by Hamilton Depression Scale score \< 9 and Anxiety Scale score \< 14
- No severe constipation, not meeting the diagnostic criteria for Rome III chronic constipation; No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a...
- Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.
What rules you out
- PD-RBD exclusion criteria:
- Parkinsonism plus syndrome and secondary parkinsonism such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism...
- Taking any probiotics or prebiotics (including lactulose) or antibiotics within 2 months before enrollment
- Adjustment of Parkinson's disease medication within 1 month before enrollment; In group 1 month before taking clonazepam and benzodiazepines medicine melatonin, etc.
- With the following diseases such as Alzheimer's disease, malignant tumor, spinal cord lesions, epilepsy, autonomic nerve disease (urinary retention, urinary incontinence or orthostatic hypotension, vertical drop in...
- Patients with anxiety or depression and taking medication
- Serious cardiovascular diseases (such as the American heart association heart function class for Ⅲ - Ⅳ of congestive heart failure, the 6 month history of myocardial infarction, etc.)
- Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; Serum creatinine is higher than the upper limit...
- Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG;
- Known to be allergic to Bifidobacterium triple viable capsules, Bacillus licheniformis, or their excipients
- Has a history of history of drug abuse or alcohol dependence
- Were enrolled in another clinical trial at enrollment
- Refusal to participate in the study or inability to cooperate with the study investigator; The researchers judgment for doesn't fit into the group of patients. Exclusion criteria for iRBD:
- PD motor symptoms and parkinsonism were included in the PD-RBD group; "Parkinsonism plus syndrome and secondary parkinsonism, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia...
- Into the group 2 months before taking any probiotics and prebiotics (including lactulose) or antibiotics
- Adjustment of Parkinson's disease medication within 1 month before enrollment; In group 1 month before taking clonazepam and benzodiazepines medicine melatonin, etc.
- With the following diseases, including but not limited to obstructive sleep apnea syndrome, Alzheimer disease, malignant tumor, spinal cord lesions, epilepsy, autonomic nerve disease (urinary retention, urinary...
- Patients with severe anxiety or depression or under drug treatment;
- Severe cardiovascular diseases (such as congestive heart failure with American Heart Association functional class Ⅲ-Ⅳ, history of myocardial infarction within 6 months, etc.);
- Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; The serum creatinine was higher than the upper...
- Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG;
- Known to be allergic to Bifidobacterium triple viable capsules, Bacillus licheniformis, or their excipients;
- With a history of drug abuse or alcohol dependence
- Were enrolled in another clinical trial at enrollment;
- Refused into groups, and can cooperate with researchers; Patients who were judged by the investigator to be ineligible for enrollment. Healthy people exclusion criteria:
- Patients with Parkinson's disease motor symptoms and met the diagnosis of parkinsonism were included in PD-RBD group; "Parkinsonism plus syndrome and secondary parkinsonism, such as multiple system atrophy, progressive...
- Patients with severe anxiety or depression or under drug treatment;
- Severe cardiovascular diseases (such as congestive heart failure with American Heart Association functional class Ⅲ-Ⅳ, history of myocardial infarction within 6 months, etc.)
- Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; The serum creatinine was higher than the upper...
- Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG; 9) known to the bifidobacterium triple viable capsules, bacillus licheniformis, or its accessories, and other allergies;
- With a history of drug abuse or alcohol dependence
- Were enrolled in another clinical trial at enrollment;
- Refused into groups, and can cooperate with researchers; The researchers judgment for doesn't fit into the group of patients.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.