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

NCT ID: NCT03705520

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-05
• Study Completion Date: 2023-05-31

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.

Detailed Description

First, a cross sectional study where the investigators will compare microbiome composition in subsets of PD and Multiple System Atrophy (MSA) patients whose household control agree to provide stool samples as well. Each household control subject will be evaluated to ensure there is no clinical evidence of neurological disorders including PD. Also, these subjects will complete a 24 hour diet recall questionnaire before stool collection and validated 3 month food frequency questionnaire to collect dietary information similar to PD patients. Each subject (including PD subjects) will complete a smell questionnaire and a sleep questionnaire to determine whether these "control" subjects have loss of smell or have REM sleep disorders because these conditions increase the risk of PD. For assessing smell, investigators will use the UPSIT questionnaire. For assessing REM sleep disorder, investigators will use RBD1Q which consists of a single question, answered "yes" or "no," as follows: "Has the subject ever been told, or suspected themselves that they seem to 'act out their dreams' while asleep (for example, punching, flailing their arms in the air, making running movements, etc.)?"

Second, in the longitudinal study, the investigators will collect stool every 3 months with 3 day diet questionnaire prior to each collection over 12 months and determine microbiome composition over time. Investigators will correlate the microbiome data with PD symptoms, diet and response to treatment and progression of disease. These studies will determine whether disease progression and factors such as PD medications and diet significantly impact microbiome composition. Furthermore, the investigators will determine whether changes in SCFA-producing bacteria and/or abnormal SCFA profiles correlate with severity of PD symptoms.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cross-Sectional

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

No interventions assigned to this group

Logitundinal

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

PD Subjects Inclusion:

• 40-80 years of age
• Previously diagnosed with Parkinson's disease
• Parkinson's disease stage between 1-4
• Are willing to participate in the study

Healthy control/ Spouse/ 1st degree relative Inclusion:

• 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

Exclusion Criteria

PD Subjects Exclusion:

• 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.

Healthy control/ Spouse/ 1st degree relative Exclusion:

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Institute of Technology

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ali Keshavarzian

Director, Division of Digestive Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Keshavarzian, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Gian Pal, MD

Role: PRINCIPAL_INVESTIGATOR

Rush Univeristy Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

ORA 16111903

Identifier Type: -

Identifier Source: org_study_id