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

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated December 2, 2024 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Eligibility criteria shortened, about 118 wordsv2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06710574
Lead Sponsor Beijing Friendship Hospital
Conditions
(from sponsor)
Parkinson Disease, Movement Disorders, Rapid Eye Movement Sleep Behavior Disorder, Gut Microbiomes, Magnetic Resonance Imaging (MRI), Probiotic
Related terms Movement Disorders, Parkinson Disease, REM Sleep Behavior Disorder
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov