RecruitingPhase 4NCT06710574

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


Sponsor

Beijing Friendship Hospital

Enrollment

120 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study uses brain imaging and other tests to understand how probiotics (beneficial gut bacteria) might help improve REM sleep behavior disorder (RBD) — a condition where people act out their dreams — in patients with Parkinson's disease. **You may be eligible if...** - You are between 40 and 80 years old - You have been diagnosed with Parkinson's disease (idiopathic) - Your Parkinson's is at stage 3 or below (can still walk independently) - You have been diagnosed with REM sleep behavior disorder confirmed by a sleep study - You do not have dementia, severe depression, or severe anxiety - Your Parkinson's and sleep symptoms have been stable for at least a month **You may NOT be eligible if...** - You have dementia (scored below 24 on a mental status test) - You have obstructive sleep apnea as the cause of your sleep symptoms - Your symptoms have recently changed or your medications were recently adjusted Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-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

DRUGiRBD

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.


Locations(1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

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NCT06710574


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