Deep Brain Stimulation, Gastrointestinal Microbiome
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. \> 18 years of age; 2. Primary Parkinson's disease diagnosed according to British Brain Bank criteria (Hoehn and Yahr); 3. Deep brain stimulator therapy; 4. Sign the informed consent.
Exclusion criteria
1. Use of probiotics or probiotics during the study; 2. Use antibiotics against intestinal bacteria at present or within the last 1 month; 3. With cognitive dysfunction or mental illness; 4. With severe diseases or is not expected to survive for more than a year; 5. A history of gastrointestinal surgery; 6. AIDS patients, hepatitis B/C positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gut microbiota | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | Analyzed by 16sRNA sequencing of feces |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosage of anti-Parkinson's agent | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | — |
| Change in blood biomarkers of neuroinflammation and alpha-synuclein | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | Comparing the changes of blood biomarkers such as neuroinflammation (TNF-alpha, IL-6, LPS) and alpha-synuclein |
| Frequency of defecation | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | — |
| Change in the score of Unified Parkinson's Disease Rating Scales | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | 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. |
| Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39) | Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy | Change in PDQ-39 scores, higher scores mean a worse outcome |
Countries
China
Contacts
Primary ContactLing Zhou
Outcome results
None listed