Colon Tissue Biopsy for Parkinson's Disease

Overseen By Dimitri Duvilaire

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Antibiotics, Corticosteroids, Probiotics, Anticoagulants

Disqualifiers: Pregnancy, GI disease, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how immune cells in the gut might affect autoimmune and neurologic diseases. Researchers aim to determine if a connection exists between these gut cells and conditions like multiple sclerosis or lupus. Individuals needing a colonoscopy as part of their regular care, or those willing to undergo one for research, are invited to participate, including those with neurologic or autoimmune issues and healthy individuals. The goal is to better understand these diseases and potentially discover new treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking discoveries.

Do I need to stop taking my current medications for the trial?

You may need to stop certain medications before joining the trial. Specifically, you cannot use antibiotics within 3 months, corticosteroids within 2 weeks, or probiotics within 2 weeks of the procedure. If you're on anticoagulant medication, you may also be excluded.

What prior data suggests that colon tissue biopsy is safe?

Research has shown that colon tissue biopsies are generally safe and well-tolerated. In a study involving mostly Thai men with early HIV infection, the biopsies proved to be safe. The side effects were mild and expected, all classified as grade 1, indicating they were minor and not serious. Therefore, for those considering joining a trial involving a colon biopsy, past research suggests the procedure is unlikely to cause significant problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the connection between intestinal immunity and neurological diseases, a relatively uncharted territory. Unlike traditional approaches that focus mainly on direct neurological interventions, this study looks at how the immune system in the gut might influence neurological conditions. This could open up entirely new pathways for understanding and potentially treating these diseases. By comparing individuals with neurologic and autoimmune diseases to healthy individuals, researchers hope to uncover insights that could lead to innovative treatment strategies.

What evidence suggests that colon tissue biopsy is effective for studying Parkinson's disease?

Research has shown that examining colon tissue samples can help detect signs of Parkinson's disease by identifying specific proteins related to the condition. Studies have found that people with Parkinson's often have high levels of a protein called alpha-synuclein in their colon tissues. One study found this protein in large amounts in the colon, suggesting it might be a marker for the disease. Another study discovered that a certain form of this protein was present in about 45.5% of stomach samples from Parkinson's patients. This evidence suggests that analyzing colon tissues could aid in understanding and possibly identifying Parkinson's disease. Participants in this trial will undergo colon tissue biopsy to further investigate these findings. ^{6 7 8 9 10}

Who Is on the Research Team?

Erin Longbrake

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

I am recommended to have a colonoscopy as part of my regular health care or am willing to have one for research.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants undergo colonoscopy and/or upper endoscopy to provide tissue biopsies from the gastrointestinal mucosa

1 day

1 visit (in-person)

Analysis

Characterization of immune cells and microbiome analysis using advanced sequencing technologies

5 years

Follow-up

Participants are monitored for any changes in immune cell profiles and microbiome composition

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Colon Tissue Biopsy

How Is the Trial Designed?

Group I: Individuals with neurologic diseases Experimental Treatment 1 Intervention

Group II: Individuals with known or suspected autoimmune diseases Experimental Treatment 1 Intervention

Group III: Healthy Individuals Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6282510/

Detection of alpha‐synuclein conformational variants from ...

We retrieved a total of 113 tissue blocks from 51 PD patients and 50 blocks from 21 HC, from ~200 Discovery participants declaring a previous GI biopsy. Recall ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667242125001769

Evaluation of an Antibody Panel for Alpha-Synuclein ...

All tested antibodies valuably detected aSyn pathology in the PD substantia nigra. Native aSyn was observed at high levels in colonic tissue.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07217054

Colonic Tissue Biopsy Detection of Phosphorylated Alpha ...

The goal of this observational study is to learn whether tissue samples taken from the colon during routine colonoscopy can detect signs of Parkinson's disease ...

4.

nature.com

nature.com/articles/s41531-025-01152-3

Cognitive function correlates with gastric alpha-synuclein ...

In this study, pathological AS-seeding activity was observed in 45.5% (10/22) of stomach biopsies obtained from patients with PD. The positivity ...

5.

michaeljfox.org

michaeljfox.org/grant/detecting-colonic-alpha-synuclein-antibody-specific-disease-associated-forms-biomarker

Detecting Colonic Alpha-synuclein with an Antibody ...

Hypothesis: We hypothesize that staining colon biopsy tissues with 5G4 will be able to sensitively and specifically discriminate individuals with PD from those ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7043900/

Feasibility and safety of research sigmoid colon biopsy in a ...

In this cohort of mostly Thai MSM with AHI, sigmoid colon biopsies were safe and well tolerated. The biopsy-related AEs were all grade 1, were largely expected ...

7.

neurology.org

neurology.org/doi/10.1212/NXI.0000000000000362

Mucosal biopsy shows immunologic changes of the colon ...

Our findings indicate a disturbed homeostasis of colonic DCs and Tregs in patients with MS which could be associated with colonic SCFA depletion.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11250647/

Biopsy samples from patients with irritable bowel syndrome ...

Nerve activation by biopsy supernatants is an IBS hallmark that occurs throughout the gut, unrelated to mast cell density or histamine concentration.

9.

thelancet.com

thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00586-3/fulltext

Evaluation of intestinal biopsy tissue preservation methods ...

Evaluation of intestinal biopsy tissue preservation methods to facilitate large-scale mucosal microbiota research

10.

neurology.org

neurology.org/doi/10.1212/NXI.0000000000200410

Assessing Commercial Tissue-Based Assays for ...

The performance of commercial IIF-TBAs for IC-Abs detection is suboptimal, exhibiting high false-negative rates of 25%–35%.