Targeting Diet-Microbiome Interactions in the Pathogenesis of Parkinson's Disease

NCT03705520 | Completed

• 1 other identifier: ORA 16111903
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the microbiome of medicated and non-medicated subjects diagnosed with Parkinson's disease. Where available, in comparison to the microbiome of a healthy spouse or 1st degree relative.

Conditions

Parkinson Disease

Keywords

PD; Parkinson's; Parkinson's Disease; Microbiome

Outcome Measures

Primary Outcomes (1)

• Study microbiome composition to explain the exact nature of the dysbiosis (microbial imbalance)

  The investigators anticipate confirming their prior findings that patients with PD have dysbiosis, and further identifying the nature of the dysbiosis including changes at the species and strain level.

  4 years

Secondary Outcomes (2)

• Identify the potential contributing factors for dysbiosis in PD

  4 years

• Determine how dysbiosis promotes PD

  4 years

Study Arms (2)

Cross-Sectional

This cohort is composed of only medicated PD subjects and their spouse or 1st degree relative.

Logitundinal

This cohort is composed of only non-medicated PD subjects and their spouse or first degree relative.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population will be selected from the neurology clinic, as well as a self-referrals.

You may qualify if:

• years of age
• Previously diagnosed with Parkinson's disease
• Parkinson's disease stage between 1-4
• Are willing to participate in the study
• Adults 40-80 years of age
• No clinical evidence of neurological disorders including Parkinson's disease
• Live in the same household as the Parkinson Disease patient or is a first degree relative of the PD patient or an independent healthy control
• Are willing to participate in the study

You may not qualify if:

• History of GI diseases (except for hemorrhoids or occasional (\<3 times a week) heartburn) like Inflammatory bowel disease or Celiac disease.
• Antibiotic use within last 12 weeks.
• Use of probiotic supplement except yogurt.
• Intentional change in diet.
• Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed.
• History of GI diseases (except for hemorrhoids or occasional (\<3 times a week) heartburn) like Inflammatory bowel disease or Celiac disease.
• Antibiotic use within last 12 weeks.
• Use of probiotic supplement except yogurt.
• Intentional change in diet.
• Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed

Sponsors & Collaborators

• Rush University Medical Center: lead
• California Institute of Technology: collaborator
• Purdue University: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ali Keshavarzian, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Gian Pal, MD

  Rush Univeristy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Digestive Diseases

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 15, 2018
• Study Start: May 5, 2018
• Primary Completion: August 31, 2022
• Study Completion: May 31, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)