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

NCT06710574 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-12-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-06-01
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06710574 on ClinicalTrials.gov