Deep Brain Stimulation Therapy and Intestinal Microbiota

Study Overview
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Brief Summary
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This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS.

Official Title
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Effect of Deep Brain Stimulation Therapy on Intestinal Microbiota in Patients With Parkinson's Disease

Conditions
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Deep Brain Stimulation, Gastrointestinal Microbiome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years of age; Primary Parkinson's disease diagnosed according to British Brain Bank criteria (Hoehn and Yahr); Deep brain stimulator therapy; Sign the informed consent. Exclusion Criteria: Use of probiotics or probiotics during the study; Use antibiotics against intestinal bacteria at present or within the last 1 month; With cognitive dysfunction or mental illness; With severe diseases or is not expected to survive for more than a year; A history of gastrointestinal surgery; AIDS patients, hepatitis B/C positive.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gut microbiota | Analyzed by 16sRNA sequencing of feces | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | 
| Change in gut microbiota | Analyzed by 16sRNA sequencing of feces | Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood biomarkers of neuroinflammation and alpha-synuclein | Comparing the changes of blood biomarkers such as neuroinflammation (TNF-alpha, IL-6, LPS) and alpha-synuclein | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | 
| Change in blood biomarkers of neuroinflammation and alpha-synuclein | Comparing the changes of blood biomarkers such as neuroinflammation (TNF-alpha, IL-6, LPS) and alpha-synuclein | Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy | 
| Frequency of defecation |  | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | 
| Frequency of defecation |  | Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy | 
| Dosage of anti-Parkinson's agent |  | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | 
| Dosage of anti-Parkinson's agent |  | Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy | 
| Change in the score of Unified Parkinson's Disease Rating Scales | It is consisted of six scales, each scale is graded on a scale of 5 (0-4), with zero being normal and 4 being severe. | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | 
| Change in the score of Unified Parkinson's Disease Rating Scales | It is consisted of six scales, each scale is graded on a scale of 5 (0-4), with zero being normal and 4 being severe. | Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy | 
| Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39) | Change in PDQ-39 scores, higher scores mean a worse outcome | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | 
| Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39) | Change in PDQ-39 scores, higher scores mean a worse outcome | Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy |