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Parkinson's Disease Biomarkers in Gut Nerve Cells

This observational study is looking for early signs of Parkinson's disease in the gut. Researchers believe that changes in the nerve cells and bacteria in your gut ("second brain") might reflect what's happening in your brain. If you are between 45 and 75 years old and are scheduled for a routine colonoscopy, you might be able to participate. During your colonoscopy, doctors will collect small tissue samples (biopsies) from your colon and a stool sample. The goal is to find "biomarkers" (early indicators) in these samples that could help diagnose Parkinson's disease sooner and improve our understanding of the gut-brain connection in this condition. The study aims to enroll 60 participants.

Study design
This is an observational study with a planned enrollment of 60 participants. It is not a treatment study but rather aims to collect information.
What's involved
You would provide a stool sample and have mucosal biopsies collected during your routine screening colonoscopy. This involves only one visit.
Compensation
Not stated in the trial record.
Follow-up
Biochemical changes in enteric nervous system will be measured at a single timepoint from biopsy samples.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05347407

Parkinson's Disease Biomarkers in Nerve Cells in the Gut

Recruiting
Not specifiedAges 45–75Observational
Weill Medical College of Cornell University
~60 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Colonoscopy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biochemical changes in enteric nervous system
Measured over A single timepoint will be evaluated on biopsy samples taken from subjects during routine screening colonoscopy.

Conditions

Parkinson Disease

Explore related trials

Lewy Body DementiaMultiple System AtrophyParkinson Disease

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jacqueline Burre, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
  • Virginia Gao, MD PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Virginia Gao, MD PhD
[email protected]
929-989-7898
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Biochemical changes in enteric nervous systemA 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.