---
title: Detect Parkinson using gut biopsy
nct_id: NCT05347407
status: RECRUITING
sponsor: Weill Medical College of Cornell University
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05347407"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05347407"
last_fetched: "2026-05-10T14:08:03.116Z"
source: "Parkinson's Pathways (curated)"
---
# Detect Parkinson using gut biopsy

**Goal (in five words):** Detect Parkinson using gut biopsy

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

**Trial ID:** [NCT05347407](https://clinicaltrials.gov/study/NCT05347407)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Weill Medical College of Cornell University
- **Target Enrollment:** 60 participants
- **Start Date:** 2020-12-30
- **Completion Date:** 2026-05-01
- **Conditions:** Parkinson Disease
- **Interventions:** Colonoscopy
- **Intervention Types:** PROCEDURE

## Summary For Families

Goal: to find out whether abnormal Parkinson's-related proteins in the gut, especially misfolded alpha-synuclein, mirror the pathological changes in the brain and could serve as a peripheral marker of disease. Approach: during a colonoscopy researchers take small biopsies of the enteric nervous system and run biochemical tests to detect misfolded alpha-synuclein and related protein changes, the study is observational so no new drug is given. Eligibility: adults 45 to 75 years old with Parkinson's disease or at higher risk (for example REM sleep behavior disorder or a first degree relative), Hoehn and Yahr stage 1 to 4, able to undergo colonoscopy and give informed consent; people with other non-synuclein neurodegenerative diseases, active GI disease, inability to safely stop anticoagulants, pregnancy, recent substance abuse, or serious uncontrolled medical problems are excluded.

## Eligibility

- **Minimum age:** 45 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full Criteria

```
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
```

## Locations (1)

- Weill Cornell Medicine, New York, New York, United States _(40.7143, -74.0060)_
  - Virginia Gao, MD PhD — (CONTACT) — 347-610-3475 — vig9070@med.cornell.edu
  - Jacqueline Burre, PhD — (CONTACT) — 6469626155 — jab2058@med.cornell.edu
  - Virginia Gao, M.D. PhD — (PRINCIPAL_INVESTIGATOR)
  - Jacqueline Burre, PhD — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Virginia Gao, MD PhD — (CONTACT) — 3476103475 — vig9070@med.cornell.edu
- Jacqueline Burre, PhD — (CONTACT) — 6469626155 — jab2058@med.cornell.edu

---

*Canonical: https://parkinsonspathways.com/trial/NCT05347407*  
*HTML version: https://parkinsonspathways.com/trial/NCT05347407*  
*Source data: https://clinicaltrials.gov/study/NCT05347407*