Actively Recruiting
Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease
Led by Beijing Friendship Hospital · Updated on 2024-12-02
120
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 80 years, male or female
- Diagnosed with idiopathic Parkinson's disease meeting the 2015 clinical diagnostic criteria (for PD-RBD group)
- Modified Hoehn and Yahr stage of Parkinson's disease is stage 3 or lower (for PD-RBD group)
- No dementia with Mini-Mental State Examination (MMSE) score above 24
- No depression or anxiety with Hamilton Depression Scale score below 9 and Anxiety Scale score below 14
- Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score above 5 and diagnosis confirmed by polysomnography, with obstructive sleep apnea excluded (for PD-RBD and iRBD groups)
- Stable Parkinson's and RBD symptoms and no changes in Parkinson's medications in the month before enrollment (for PD-RBD group)
- No use of benzodiazepines such as clonazepam or melatonin in the month before enrollment
- No probiotic, prebiotic, or antibiotic use for two months prior to enrollment, or a two-month washout period observed
- Willingness and ability to comply with the study protocol and provide informed consent
- Age- and gender-matched healthy controls with RBD screening questionnaire score 5 or less and exclusion of RBD and obstructive sleep apnea by polysomnography
- No severe constipation or Rome III chronic constipation diagnosis (for healthy controls)
You will not qualify if you...
- Diagnosis of parkinsonism plus syndromes or secondary parkinsonism such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or other non-primary parkinsonism
- Use of probiotics, prebiotics (including lactulose), or antibiotics within two months before enrollment
- Adjustment of Parkinson's disease medication within one month before enrollment
- Use of benzodiazepines such as clonazepam or melatonin within one month before enrollment
- Diseases including Alzheimer's disease, malignant tumors, spinal cord lesions, epilepsy, autonomic nerve disorders (urinary retention, incontinence, or orthostatic hypotension), recent cerebrovascular disease within three months
- Patients with anxiety or depression receiving medication
- Severe cardiovascular diseases such as congestive heart failure class II-III, recent myocardial infarction within six months
- Severe liver or kidney dysfunction with elevated enzyme or creatinine levels above 1.5 times normal
- Pregnant or breastfeeding women, or positive pregnancy test in women aged 40-60
- Known allergy to Bifidobacterium triple viable capsules, Bacillus licheniformis, or their components
- History of drug abuse or alcohol dependence
- Participation in another clinical trial at enrollment
- Refusal or inability to cooperate with study procedures or judged unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
Actively Recruiting
Research Team
H
Houzhen Tuo Principal Investigator, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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