Deep Brain Stimulation Therapy and Intestinal Microbiota

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

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 Overview

• Status: Recruiting
• Conditions: Deep Brain Stimulation; Gastrointestinal Microbiome

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Ling Zhou; Phone Number: +8615895918786; Email: lingzhou531@foxmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • the Hospital Research Ethics Committee of the First Affiliated Hospital of Nanjing Medical University
      • Contact: Yue Wang; Email: jsphkjwy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Parkinson's disease and are expected to undergo DBS therapy

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Chair: Cunming Liu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Ling Zhou

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No