Investigating probiotics to improve sleep behavior in Parkinson's disease

Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving Rapid Eye Movement Behavior Disorder with Parkinson's Disease

This study is testing whether taking probiotics can help improve sleep problems in people with Parkinson's disease.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06710574 on ClinicalTrials.gov

What this trial studies

This study aims to explore the effects and mechanisms of probiotic intervention on improving rapid eye movement sleep behavior disorder (RBD) in patients with Parkinson's disease (PD). It will enroll patients with PD-RBD, idiopathic RBD, and healthy controls, collecting multimodal imaging data and clinical assessments before and after probiotic treatment. The research will analyze changes in imaging parameters, microbiota abundance, and metabolite concentrations to understand how probiotics may alleviate RBD symptoms. Additionally, a PD mouse model will be created to further investigate the biochemical mechanisms involved.

Who should consider this trial

Good fit: Ideal candidates include adults aged 40-80 with idiopathic Parkinson's disease and diagnosed RBD who meet specific clinical criteria.

Not a fit: Patients with advanced Parkinson's disease, dementia, or those currently using probiotics or certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel therapeutic approach to alleviate sleep disturbances in Parkinson's disease patients.

How similar studies have performed: While the use of probiotics in neurological conditions is emerging, this specific approach to RBD in Parkinson's disease is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Inclusion criteria 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.

Inclusion criteria 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.

Inclusion criteria for healthy subjects

* 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 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.

Exclusion Criteria:

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, post-encephalitis parkinsonism, or any other non-primary 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 blood pressure in five minutes more than 30/15 MMHG), etc.; New onset of cerebrovascular disease or severe sequelae of cerebrovascular disease within 3 months, affecting the assessment
* 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 of normal value 1. 5 times
* 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 degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary Parkinson's disease;"
* 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 incontinence or orthostatic hypotension, vertical drop in blood pressure in five minutes more than 30/15 MMHG), etc.; 3 month new cerebrovascular disease or severe cerebrovascular disease sequela, impact assessment;
* 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 limit of the normal range. 5 times;
* 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 subjects 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 supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary Parkinson's disease;" 2) taking any probiotics or prebiotics (including lactulose) or antibiotics within 2 months before enrollment; 1 month before the 3) into the group of Parkinson's disease medication adjustment; Benzodiazepines such as clonazepam and melatonin were taken within 1 month before enrollment. 4) combined with the following diseases, including but not limited to obstructive sleep apnea syndrome, Alzheimer's disease, malignant tumors, spinal cord lesions, epilepsy, autonomic disorders (urinary retention, urinary incontinence or orthostatic hypotension, blood pressure drop more than 30/15 MMHG after 5 minutes of standing), etc.; New onset of cerebrovascular disease or severe sequelae of cerebrovascular disease within 3 months, affecting the assessment
* 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 limit of the normal range. 5 times
* 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.

Where this trial is running

Beijing

• Beijing Friendship Hospital, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Houzhen Tuo Principal Investigator, PhD

Conditions Parkinson Disease; Movement Disorders; Rapid Eye Movement Sleep Behavior Disorder; Gut Microbiomes; Magnetic Resonance Imaging; Probiotic; Parkinson's disease; Multimodel Magnetic Resonance Imaging