- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705520
Targeting Diet-Microbiome Interactions in the Pathogenesis of Parkinson's Disease
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Cross-Sectional
This cohort is composed of only medicated PD subjects and their spouse or 1st degree relative.
|
Logitundinal
This cohort is composed of only non-medicated PD subjects and their spouse or first degree relative.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study microbiome composition to explain the exact nature of the dysbiosis (microbial imbalance)
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.
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify the potential contributing factors for dysbiosis in PD
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.
|
4 years
|
Determine how dysbiosis promotes 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.
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gian Pal, MD, Rush Univeristy Medical Center
- Principal Investigator: Ali Keshavarzian, MD, Rush University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORA 16111903
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain