Parkinson DiseasePD-ENSNCT05347407
Parkinson's Disease Biomarkers in Nerve Cells in the Gut
An observational study of Parkinson Disease, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Parkinson's disease affects all the nerve cells in the body, including the ones in the gut. The gut contains its own nervous system, the enteric nervous system, and can be thought of as a "second brain". This second brain can reflect what is going on in the actual brain. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2020to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with several stages of Parkinson's disease (PD), aged 45 to 75 years old and healthy age-matched control subjects
Who may be able to join
- Age 45-75 years old
- Parkinson's Disease defined by the modified UK Parkinson's Disease Society Brain Bank criteria, at risk for the development of Parkinson's disease including REM sleep behavior disorder and/or at least one first degree relative with PD or related disorder, and diseases related to Parkinson's disease including the synucleinopathies Lewy Body Dementia and Multiple System Atrophy.
- Baseline Hoehn \& Yahr score 1-4
- No contraindications to undergoing screening colonoscopy
- Able to give informed consent for study participation
Who cannot join
- Clinical features suggestive of a neurodegenerative diagnosis other than synucleinopathy.
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease, Progressive Supranuclear Palsy (PSP), and Corticobasal syndrome.
- Significant concomitant medical disease limiting life expectancy to less than 24 months from study inclusion, or significant and serious concomitant medical disease that is poorly controlled
- Signs of active malignant disease or other clinically relevant abnormality on chest x-ray
- Active or untreated gastrointestinal disease
- Inability to temporarily stop anti-platelet agents or other anti-coagulants without significant risk
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- Known substance abuse (recent history of abuse of alcohol or other drugs such as barbiturates, cannabinoids and amphetamines) within last 5 years
- Contraindication to colonoscopy or associated anesthesia
- Pregnancy
- In the opinion of the investigator, any other condition regarded as making subject unsuitable for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jacqueline Burre, PhD contact
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Virginia Gao, MD PhD, 929-989-7898, vig9070@med.cornell.edu
Jacqueline Burre, PhD, jab2058@med.cornell.edu
About this study
Official title: Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
Parkinson's disease affects all the nerve cells in the body, including the ones in the gut. The gut contains its own nervous system, the enteric nervous system, and can be thought of as a "second brain". This second brain can reflect what is going on in the actual brain. This study is being done to look for biomarkers, or early indicators of developing Parkinson's disease, in the microbiome and in the gut tissue taken during routine screening colonoscopy. People aged 45 and over who are due for their routine screening colonoscopy are eligible to participate.
Read the detailed description
Parkinson's disease affects 1 in 100 people over the age of 65, but the time between disease onset and diagnosis can be many months or years. Interestingly, the pathological hallmarks of Parkinson's disease and other synucleinopathies in the brain can also be seen in the nerve cells in the gut. Parkinson's disease may begin in the gut, at least in some people. Unlike the nerve cells in the brain, the nerve cells in the gut are accessible through routine colonoscopy, and so can be obtained by minimally invasive biopsy for the study in the laboratory. In addition, there are links between gut microbes, including bacteria, and the development of Parkinson's disease.
This research study is being done to discover whether the pathology in enteric nerve cells and the types of bacteria in the gut can serve as an indicator of Parkinson's disease. The goal of this research is to develop a biomarker that could help in earlier diagnosis. It also aims to improve the understanding of the link between the gut and brain in Parkinson's disease.
The American Cancer Society recommends screening colonoscopy starting from the age of 45 for the prevention of colon cancer. The study requires only one visit, and study samples will be collected as part of a colonoscopy needed for routine care.
- Conditions
- Parkinson Disease
- Being tested
- Colonoscopy
- Keywords
- microbiome, Parkinson's, RBD, Alpha Synuclein, enteric nervous system
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Patients will be provided with a kit and be asked to bring a stool sample to their colonoscopy appointment. Mucosal biopsies will be collected with standard forceps during colonoscopy. If the physician determines that the patient will need colonoscopy with biopsy as part of their routine clinical care, they will take 6-8 additional biopsies for use in the research study. If the physician determines that the patient will need colonoscopy without biopsy as part of their routine clinical care, they will take 6-8 biopsies for use in the research study only. The collection of additional biopsies will add an estimated two minutes to the whole procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy Patients Receives: Procedure: Colonoscopy | |
| Parkinson's Disease | Patients diagnosed with Parkinson's disease Receives: Procedure: Colonoscopy | |
| At risk for PD | Defined as REM sleep behavior disorder, known genetic risk factor, and/or first degree relatives with PD Receives: Procedure: Colonoscopy | |
| Dementia with Lewy Bodies | Patients diagnosed with Dementia with Lewy Body Disease Receives: Procedure: Colonoscopy | |
| Multiple System Atrophy | Patients diagnosed with Multiple System Atrophy Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical changes in enteric nervous system
The primary objective of the study is to assess the abundance and subcellular distribution of alpha-synuclein and other Parkinson's disease-related proteins in the enteric nervous system of PD patients and healthy controls.
Measured: A single timepoint will be evaluated on biopsy samples taken from subjects during routine screening colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start30 Dec 2020
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
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 Weill Medical College of Cornell UniversityThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Burre, PhD, Principal investigator, Weill Medical College of Cornell UniversityVirginia Gao, MD PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347407
- Sponsor's protocol ID
- 19-09020813
- Other IDs
- 1R01NS136423-01A1
- Acronym
- PD-ENS
- Status last verified
- May 2026
- First submitted
- 20 Apr 2022
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
- ClinicalTrials.gov ID
- NCT05347407
- Acronym / sponsor ID
- PD-ENS / 19-09020813
- Conditions
- Parkinson Disease
- Keywords
- microbiome, Parkinson's, RBD, Alpha Synuclein, enteric nervous system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Apr 2022 (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.
Parkinson's disease affects all the nerve cells in the body, including the ones in the gut. The gut contains its own nervous system, the enteric nervous system, and can be thought of as a "second brain". This second brain can reflect what is going on in the actual brain. This study is being done to look for biomarkers, or early indicators of developing Parkinson's disease, in the microbiome and in the gut tissue taken during routine screening colonoscopy. People aged 45 and over who are due for their routine screening colonoscopy are eligible to participate.
Detailed description
Parkinson's disease affects 1 in 100 people over the age of 65, but the time between disease onset and diagnosis can be many months or years. Interestingly, the pathological hallmarks of Parkinson's disease and other synucleinopathies in the brain can also be seen in the nerve cells in the gut. Parkinson's disease may begin in the gut, at least in some people. Unlike the nerve cells in the brain, the nerve cells in the gut are accessible through routine colonoscopy, and so can be obtained by minimally invasive biopsy for the study in the laboratory. In addition, there are links between gut microbes, including bacteria, and the development of Parkinson's disease.
This research study is being done to discover whether the pathology in enteric nerve cells and the types of bacteria in the gut can serve as an indicator of Parkinson's disease. The goal of this research is to develop a biomarker that could help in earlier diagnosis. It also aims to improve the understanding of the link between the gut and brain in Parkinson's disease.
The American Cancer Society recommends screening colonoscopy starting from the age of 45 for the prevention of colon cancer. The study requires only one visit, and study samples will be collected as part of a colonoscopy needed for routine care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: ColonoscopyHealthy Patients |
| Parkinson's Disease | – | Procedure: ColonoscopyPatients diagnosed with Parkinson's disease |
| At risk for PD | – | Procedure: ColonoscopyDefined as REM sleep behavior disorder, known genetic risk factor, and/or first degree relatives with PD |
| Dementia with Lewy Bodies | – | Procedure: ColonoscopyPatients diagnosed with Dementia with Lewy Body Disease |
| Multiple System Atrophy | – | Procedure: ColonoscopyPatients diagnosed with Multiple System Atrophy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with several stages of Parkinson's disease (PD), aged 45 to 75 years old and healthy age-matched control subjects
Key inclusion criteria (5 listed)
- Age 45-75 years old
- Parkinson's Disease defined by the modified UK Parkinson's Disease Society Brain Bank criteria, at risk for the development of Parkinson's disease including REM sleep behavior disorder and/or at least one first degree relative with PD or related disorder, and diseases related to Parkinson's disease including the synucleinopathies Lewy Body Dementia and Multiple System Atrophy.
- Baseline Hoehn \& Yahr score 1-4
- No contraindications to undergoing screening colonoscopy
- Able to give informed consent for study participation
Key exclusion criteria (10 listed)
- Clinical features suggestive of a neurodegenerative diagnosis other than synucleinopathy.
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease, Progressive Supranuclear Palsy (PSP), and Corticobasal syndrome.
- Significant concomitant medical disease limiting life expectancy to less than 24 months from study inclusion, or significant and serious concomitant medical disease that is poorly controlled
- Signs of active malignant disease or other clinically relevant abnormality on chest x-ray
- Active or untreated gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyPatients will be provided with a kit and be asked to bring a stool sample to their colonoscopy appointment. Mucosal biopsies will be collected with standard forceps during colonoscopy. If the physician determines that the patient will need colonoscopy with biopsy as part of their routine clinical care, they will take 6-8 additional biopsies for use in the research study. If the physician determines that the patient will need colonoscopy without biopsy as part of their routine clinical care, they will take 6-8 biopsies for use in the research study only. The collection of additional biopsies will add an estimated two minutes to the whole procedure. | Procedure or surgery | At risk for PD, Control, Dementia with Lewy Bodies, Multiple System Atrophy, Parkinson's Disease |
Primary outcome
Biochemical changes in enteric nervous system
Time frame: A single timepoint will be evaluated on biopsy samples taken from subjects during routine screening colonoscopy.
The primary objective of the study is to assess the abundance and subcellular distribution of alpha-synuclein and other Parkinson's disease-related proteins in the enteric nervous system of PD patients and healthy controls.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Jacqueline Burre, PhD contact
Jacqueline Burre, PhD principal investigator
Weill Medical College of Cornell University
Virginia Gao, MD PhD principal investigator
Weill Medical College of Cornell University
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 Weill Medical College of Cornell University 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginia Gao, MD PhD (929-989-7898, vig9070@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical changes in enteric nervous system (time frame: A single timepoint will be evaluated on biopsy samples taken from subjects during routine screening colonoscopy.). 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 22 May 2026.