Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05347407

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Colonoscopy

Study Details

Brief 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. 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.

Conditions

Parkinson Disease

Study ID

NCT05347407

Start date

Dec 30, 2020

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Control

Healthy Patients

Parkinson's Disease

Patients diagnosed with Parkinson's disease

At risk for PD

Defined as REM sleep behavior disorder, known genetic risk factor, and/or first degree relatives with PD

Dementia with Lewy Bodies

Patients diagnosed with Dementia with Lewy Body Disease

Multiple System Atrophy

Patients diagnosed with Multiple System Atrophy

Interventions

Colonoscopy

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.

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. ]

Central Contacts and Locations

Central contacts

Virginia Gao, MD PhD

929-989-7898vig9070@med.cornell.edu

Jacqueline Burre, PhD

jab2058@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Virginia Gao, MD PhD

929-989-7898vig9070@med.cornell.edu

Jacqueline Burre, PhD

jab2058@med.cornell.edu

Principal Investigator:

Virginia Gao, M.D. PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • microbiome
  • Parkinson's
  • RBD
  • Alpha Synuclein
  • enteric nervous system

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-05-22.