Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving Rapid Eye Movement Behavior Disorder with Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: t
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• 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

• No depression or anxiety, as indicated by Hamilton Depression Scale score \< 9 and Anxiety Scale score \< 14

• Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score \> 5, diagnosed with RBD based on polysomnography results, and exclusion of obstructive sleep apnea

• Stable condition of Parkinson's disease motor symptoms and RBD symptoms in the month prior to enrollment, with no adjustments to Parkinson's disease medications in the month prior to enrollment

• Discontinuation of benzodiazepines such as clonazepam and melatonin in the month prior to enrollment

• No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed

• Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.

• Age between 40 and 80 years, both males and females

• Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score \> 5, diagnosed with RBD based on polysomnography results, and exclusion of obstructive sleep apnea or restless legs syndrome

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

• No depression or anxiety, as indicated by Hamilton Depression Scale score \< 9 and Anxiety Scale score \< 14

• Discontinuation of benzodiazepines such as clonazepam and melatonin in the month prior to enrollment

• No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed

• Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.

• Age between 40 and 80 years, age and gender matched with the above two groups of patients

• Rapid Eye Movement Sleep Behavior Disorder screening questionnaire score ≤ 5, exclusion of RBD or obstructive sleep apnea based on polysomnography results

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

• No depression or anxiety, as indicated by Hamilton Depression Scale score \< 9 and Anxiety Scale score \< 14

• No severe constipation, not meeting the diagnostic criteria for Rome III chronic constipation; No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed

• Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.

Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Houzhen Tuo Principal Investigator, PhD
tuohouzhen@ccmu.edu.cn
+8613683628005
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 120
Treatments
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
Sponsors
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov