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

Rush

Status

Completed

Conditions

Parkinson Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03705520

ORA 16111903

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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