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

Sponsor
Beijing Friendship Hospital
Study ID
NCT06710574
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Accepted

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
  • 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.

Study Details

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 Dates

First listed
Nov 29, 2024
Start date
Sep 1, 2022
Status verified
Oct 2024
Primary completion
Jun 1, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: idiopathic Rapid Eye Movement sleep behavior disorder (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
  • No Intervention: Parkinson's disease without Rapid Eye Movement sleep behavior disorder
    PD subjects without RBD matched for age and sex to PD with RBD, iRBD and healthy control subjects
  • No Intervention: Healthy control
    Healthy subjects without RBD matched for age and sex to PD and iRBD subjects
  • Experimental: Parkinson's disease with Rapid Eye Movement sleep behavior disorder group
    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

Primary Outcome Measure

Magnetic resonance imaging changes of brain structure and function [ Time Frame: 12 weeks ]

Central Contacts

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