Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease

Recruiting now · Phase 4

Conditions studied: Parkinson Disease, Movement Disorders, Rapid Eye Movement Sleep Behavior Disorder, Gut Microbiomes, Magnetic Resonance Imaging (MRI), Probiotic

In brief

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. The later was not reported before and the mechanism not clear. To investigate its role and mechanism, we plan to enroll patients of PD-RBD, idiopathic RBD, and healthy control, collect data of multimodal image technology before and after probiotic treatment，including resting state functional MRI，1H-MRS，123I-MIBG; analyze these data with clinical features, including UPDRS -III score, RBD-HK score , as well as the bacteria abundance and level of glutamate，GABA in blood and stool. Then, construct PD mouse model by fecal transplantation of PD patient, give or not give mouse probiotics treatment, and detect the level of glutamate, GABA, and so on, as well as α-synuclein of each brain area of each group, to explore the role and mechanism of probiotics in improving RBD and movement disorder of PD.

Key facts

Study ID: NCT06710574
Run by: Beijing Friendship Hospital
People needed: 120
Starts: 2022-09-01
Expected to finish: 2025-06-30
Last updated by the study team: 2024-12-02

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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;

Where it is running

Beijing Friendship Hospital, Capital Medical University — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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