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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-85
SponsorBeijing Friendship Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age between 40 and 80 years, both males and females

Patients with idiopathic Parkinson's disease, meeting the MDS clinical diagnostic criteria for Parkinson's disease (2015)

Modified Hoehn and Yahr stage of Parkinson's disease ≤ stage 3

No dementia, with a Mini-Mental State Examination (MMSE) score > 24

Disqualifiers

Parkinsonism plus syndrome and secondary parkinsonism such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary parkinsonism

Taking any probiotics or prebiotics (including lactulose) or antibiotics within 2 months before enrollment

Adjustment of Parkinson's disease medication within 1 month before enrollment; In group 1 month before taking clonazepam and benzodiazepines medicine melatonin, etc.

With the following diseases such as Alzheimer's disease, malignant tumor, spinal cord lesions, epilepsy, autonomic nerve disease (urinary retention, urinary incontinence or orthostatic hypotension, vertical drop in blood pressure in five minutes more than 30/15 MMHG), etc.; New onset of cerebrovascular disease or severe sequelae of cerebrovascular disease within 3 months, affecting the assessment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: idiopathic Rapid Eye Movement sleep behavior disorder (iRBD)Experimental treatment 1 intervention
Group B: Parkinson's disease without Rapid Eye Movement sleep behavior disorderNo intervention 0 interventions
Group C: Healthy controlNo intervention 0 interventions
Group D: Parkinson's disease with Rapid Eye Movement sleep behavior disorder groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Magnetic resonance imaging changes of brain structure and function

Time frame
12 weeks
2

Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale(MDS-UPDRS)

Time frame
12 weeks
3

The abundance of gut microbiota

Time frame
12 weeks

Secondary outcomes

1

Patient assessment of constipation symptom

Time frame
12 weeks
2

Epworth sleepiness score

Time frame
12 weeks
3

Hoehn-Yahr

Time frame
12 weeks
4

RBD Questionnaire-Hong Kong

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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