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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705520
• Other study ID #: ORA 16111903
• Status: Completed
• Start date: May 5, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	California Institute of Technology, Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identify the potential contributing factors for dysbiosis in PD	It is well established that environmental factors such as diet, as well as genetics, impact microbiome composition.Currently, there are no data for how environment impacts the microbiome in PD.	4 years
Secondary	Determine how dysbiosis promotes PD	The investigators will determine SCFA (Short chain fatty acids) concentrations in serum and stool from early onset PD patients and healthy controls. The investigators will correlate serum, stool data, PD symptoms and disease severity obtained through validated PD questionnaires.	4 years