Parkinson DiseaseNCT03705520
Targeting Diet-Microbiome Interactions in the Pathogenesis of Parkinson's Disease
An observational study of Parkinson Disease, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2018to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population will be selected from the neurology clinic, as well as a self-referrals.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Keywords
- PD, Parkinson's, Parkinson's Disease, Microbiome
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (2)
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.
Measured: 4 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start5 May 2018
- Primary completion31 Aug 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- California Institute of Technology, Purdue University
- Responsible party
- Principal investigator, Ali Keshavarzian, Rush University Medical Center
- Investigators
- Ali Keshavarzian, MD, Principal investigator, Rush University Medical CenterGian Pal, MD, Principal investigator, Rush Univeristy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705520
- Sponsor's protocol ID
- ORA 16111903
- Status last verified
- Jun 2023
- First submitted
- 1 Oct 2018
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifying information will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Diet-Microbiome Interactions in the Pathogenesis of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03705520
- Acronym / sponsor ID
- ORA 16111903
- Conditions
- Parkinson Disease
- Keywords
- PD, Parkinson's, Parkinson's Disease, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- California Institute of Technology, Purdue University
- Study start
- 5 May 2018 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be selected from the neurology clinic, as well as a self-referrals.
Key inclusion criteria (10 listed)
- 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
- Adults 40-80 years of age
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Identify the potential contributing factors for dysbiosis in PD
Time frame: 4 years
Determine how dysbiosis promotes PD
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No. No identifying information will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Keshavarzian, MD principal investigator
Rush University Medical Center
Gian Pal, MD principal investigator
Rush Univeristy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study microbiome composition to explain the exact nature of the dysbiosis (microbial imbalance) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.