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

NCT06710574 | Recruiting Phase 4

• 1 other identifier: 2022-P2-172
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Parkinson Disease; Movement Disorders; Rapid Eye Movement Sleep Behavior Disorder; Gut Microbiomes; Magnetic Resonance Imaging (MRI); Probiotic

Keywords

Probiotic; Parkinson's disease; Rapid Eye Movement Sleep Behavior Disorder; Multimodel Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

• Magnetic resonance imaging changes of brain structure and function

  12 weeks

• Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale(MDS-UPDRS)

  12 weeks

• The abundance of gut microbiota

  12 weeks

Secondary Outcomes (12)

• Patient assessment of constipation symptom

  12 weeks

• Epworth sleepiness score

  12 weeks

• Hoehn-Yahr

  12 weeks

• RBD Questionnaire-Hong Kong

  12 weeks

• Rapid-eye-movement Sleep Behavior Disorder Screening Questionnaire

  12 weeks

Study Arms (4)

idiopathic Rapid Eye Movement sleep behavior disorder (iRBD)

EXPERIMENTAL

Bifidobacterium triple viable capsule (Bifico Capsule, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., LTD.) 420mg, two times a day, 4 capsules each time; At the same time give the bacillus licheniformis living bacterium capsule (whole bowel capsule, northeast pharmaceutical) 0.5 g, three times a day, two at a time

Drug: iRBD

Parkinson's disease without Rapid Eye Movement sleep behavior disorder

NO INTERVENTION

PD subjects without RBD matched for age and sex to PD with RBD, iRBD and healthy control subjects

Healthy control

NO INTERVENTION

Healthy subjects without RBD matched for age and sex to PD and iRBD subjects

Parkinson's disease with Rapid Eye Movement sleep behavior disorder group

EXPERIMENTAL

Bifidobacterium triple viable capsule (Bifico Capsule, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., LTD.) 420mg, two times a day, 4 capsules each time; At the same time give the bacillus licheniformis living bacterium capsule (whole bowel capsule, northeast pharmaceutical) 0.5 g, three times a day, two at a time, keep the original anti Parkinson's drugs

Drug: PD-RBD

Interventions

PD-RBD DRUG

Bifidobacterium triple viable capsule (Bifico Capsule, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., LTD.) 420mg, two times a day, 4 capsules each time; At the same time give the bacillus licheniformis living bacterium capsule (whole bowel capsule, northeast pharmaceutical) 0.5 g, three times a day, two at a time, keep the original anti Parkinson's drugs

Parkinson's disease with Rapid Eye Movement sleep behavior disorder group

iRBD DRUG

Bifidobacterium triple viable capsule (Bifico Capsule, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., LTD.) 420mg, two times a day, 4 capsules each time; At the same time give the bacillus licheniformis living bacterium capsule (whole bowel capsule, northeast pharmaceutical) 0.5 g, three times a day, two at a time.

idiopathic Rapid Eye Movement sleep behavior disorder (iRBD)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Age between 40 and 80 years, both males and females
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Central Study Contacts

Houzhen Tuo Principal Investigator, PhD

CONTACT

+8613683628005; tuohouzhen@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: September 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)