Deep Brain Stimulation Therapy and Intestinal Microbiota

The First Affiliated Hospital with Nanjing Medical University30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Deep Brain Stimulation Gastrointestinal Microbiome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

the Hospital Research Ethics Committee of the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Change in gut microbiota

Analyzed by 16sRNA sequencing of feces

Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy

Change in gut microbiota

Analyzed by 16sRNA sequencing of feces

Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy

Secondary Outcomes

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

Time frame: 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

Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy

Frequency of defecation

Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy

Frequency of defecation

Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy

Dosage of anti-Parkinson's agent

Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy

Dosage of anti-Parkinson's agent

Central Contacts

Ling Zhou

CONTACT

+8615895918786 lingzhou531@foxmail.com

Data from ClinicalTrials.gov

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