Clinical trial NCT04855344: Deep Brain Stimulation Therapy and Intestinal Microbiota
Official title: Effect of Deep Brain Stimulation Therapy on Intestinal Microbiota in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deep Brain Stimulation
Gastrointestinal Microbiome
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease and are expected to undergo DBS therapy

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in gut microbiota
timeFrame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
measure: Change in gut microbiota
timeFrame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Secondary outcomes:
measure: Change in blood biomarkers of neuroinflammation and alpha-synuclein
timeFrame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
measure: Change in blood biomarkers of neuroinflammation and alpha-synuclein
timeFrame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
measure: Frequency of defecation
timeFrame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
measure: Frequency of defecation
timeFrame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
measure: Dosage of anti-Parkinson's agent
timeFrame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
measure: Dosage of anti-Parkinson's agent
timeFrame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
measure: Change in the score of Unified Parkinson's Disease Rating Scales
timeFrame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
measure: Change in the score of Unified Parkinson's Disease Rating Scales
timeFrame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
measure: Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
timeFrame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
measure: Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
timeFrame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the Hospital Research Ethics Committee of the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Cunming Liu
role: STUDY_CHAIR
References: