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



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - 80
Updated:10/17/2018
Start Date:May 5, 2018
End Date:May 2021
Contact:Chelsea C Franklin, BS
Email:chelsea_c_franklin@rush.edu
Phone:312-563-0688

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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.

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.

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
We found this trial at
1
site
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Ali Keshavarzian, MD
Phone: 312-563-0688
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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from
Chicago, IL
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