Rush University Medical Center
Chicago, Illinois, 60612, United States
NCT Number: NCT03705520
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.
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Notify Me40 year–80 year
All sexes
Observational
Chicago, Illinois, 60612, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
PD Subjects Inclusion:
Healthy control/ Spouse/ 1st degree relative Inclusion:
Exclusion criteria
PD Subjects Exclusion:
Healthy control/ Spouse/ 1st degree relative Exclusion:
Time frame: 4 years
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.
Time frame: 4 years
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.
Time frame: 4 years
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.
Rush University Medical Center
Other
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