NCT05347407Recruiting
Parkinson's Disease Biomarkers in Nerve Cells in the Gut
Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 20 Apr 2022
- Start date
- Dec 2020
- Primary completion date
- Jun 2028
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Parkinson disease
- NCT number
- NCT05347407
What you commit to
- Study type: Observational
- Planned participants: 60
- From Dec 2020 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
- Signs of active malignant disease or other clinically relevant abnormality on chest x-ray
- Active or untreated gastrointestinal disease
- Known substance abuse (recent history of abuse of alcohol or other drugs such as barbiturates, cannabinoids and amphetamines) within last 5 years
- In the opinion of the investigator, any other condition regarded as making subject unsuitable for the study
Lab values
- Inability to temporarily stop anti-platelet agents or other anti-coagulants without significant risk
Other
- Clinical features suggestive of a neurodegenerative diagnosis other than synucleinopathy.
- Contraindication to colonoscopy or associated anesthesia
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.