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Looking for Parkinson’s-related signs in gut nerve cells

Researchers study nerve cells in the digestive system to look for biological markers related to Parkinson’s.

Learning by observing or collecting information · Study reference: NCT05347407

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Looking for volunteers

Start (reported actual date)
2020-12-30
Main measurements finished (planned)
2028-06-30
Study finished (planned)
2028-06-30

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 45 years to 75 years · Also accepts healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Full study name & original research details

Official study title

Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain

Short title used by the registry

Parkinson's Disease Biomarkers in Nerve Cells in the Gut

Original description

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.

Further description from the registry

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 reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Observational
Interventions
Colonoscopy
Phases
Not reported
Sponsor
Weill Medical College of Cornell University
Start date reported by registry
2020-12-30 (actual)

Registry updated: 2026-05-22 · Status last verified by the registry submitter: 2026-05

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Virginia Gao, MD PhD · 929-989-7898 · vig9070@med.cornell.edu

Jacqueline Burre, PhD · jab2058@med.cornell.edu

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Weill Cornell Medicine

New York, New York, United States

Recruiting

Virginia Gao, MD PhD · 929-989-7898 · vig9070@med.cornell.edu

Jacqueline Burre, PhD · jab2058@med.cornell.edu

Virginia Gao, M.D. PhD

Jacqueline Burre, PhD

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.