NCT06710574

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objectives of this study are to explore the effects and mechanisms of probiotic intervention on improving REM sleep behavior disorder (RBD) in patients with Parkinson's disease (PD) from both clinical and animal experimental levels. The study aims to elucidate the scientific hypothesis that "probiotic intervention improves RBD in PD patients through a neuroendocrine mechanism," providing a theoretical basis for the mechanism by which probiotic intervention alleviates RBD symptoms in PD patients. Research Content: Establishing imaging detection technical processes and parameters for RBD.Collecting pre- and post-probiotic treatment imaging parameters and comparing them with RBD improvement to explore the mechanism by which probiotics improve PD patient RBD.Detecting fecal microbiota abundance and blood and fecal metabolite concentrations to discuss the biochemical mechanism by which probiotics improve PD motor symptoms and RBD. Research Methods: Patient Recruitment: Enrolling PD-RBD, iRBD, and healthy control subjects, with specific inclusion and exclusion criteria based on clinical diagnosis and symptomatology. Clinical Assessments and Tests: Utilizing standardized scales such as RBDSQ, RBD-HK, UPDRS-III, and Hoehn-Yahr staging for symptom evaluation. Conducting polysomnography (PSG) for RBD diagnosis and exclusion of other sleep disorders. Multimodal Imaging Data Collection: Employing 3.0T MRI for high-precision anatomical imaging, resting-state functional MRI (rs-fMRI), and proton magnetic resonance spectroscopy (1H-MRS) for glutamate, GABA, and other metabolites in specific brain regions. Performing 123I-MIBG cardiac scintigraphy to assess cardiac sympathetic nerve function. Laboratory Tests: Measuring concentrations of glutamate, GABA, acetylcholine, and other metabolites in blood and fecal samples. Assessing fecal microbiota abundance through 16S rRNA gene sequencing. Research Methods: Patient Recruitment: Enrolling PD-RBD, iRBD, and healthy control subjects, with specific inclusion and exclusion criteria based on clinical diagnosis and symptomatology. Clinical Assessments and Tests: Utilizing standardized scales such as RBDSQ, RBD-HK, UPDRS-III, and Hoehn-Yahr staging for symptom evaluation. Conducting polysomnography (PSG) for RBD diagnosis and exclusion of other sleep disorders. Multimodal Imaging Data Collection: Employing 3.0T MRI for high-precision anatomical imaging, resting-state functional MRI (rs-fMRI), and proton magnetic resonance spectroscopy (1H-MRS) for glutamate, GABA, and other metabolites in specific brain regions. Performing 123I-MIBG cardiac scintigraphy to assess cardiac sympathetic nerve function. Laboratory Tests: Measuring concentrations of glutamate, GABA, acetylcholine, and other metabolites in blood and fecal samples. Assessing fecal microbiota abundance through 16S rRNA gene sequencing. Data Analysis: Correlating imaging data, clinical symptoms, microbiota abundance, and metabolite concentrations to explore the mechanisms of probiotic intervention in PD and RBD.

Conditions

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

Interventions

Type	Name	Description
DRUG	PD-RBD	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	iRBD	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-06-01
• Completion: 2025-06-30
• First posted: 2024-11-29
• Last updated: 2024-12-02

Locations

1 site across 1 country: China