Intestinal Immunity in Neurologic Disease

NCT06329453 | Recruiting

• 1 other identifier: 2000033081
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases.

Conditions

Multiple Sclerosis; Parkinson Disease; REM Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (1)

• Characterization of immune cells from the gastrointestinal mucosa

  Gastrointestinal mucosa cells will be characterized using sRNA measured through high-throughput sequencing with quantitative polymerase chain reaction (qPCR) validation.

  Through study completion, an average of 5 years

Secondary Outcomes (2)

• Evaluate spatial transcriptomics of intestinal tissue

  Through study completion, an average of 5 years

• Characterize the microbiome at different anatomic sites within the gastrointestinal tract

  Through study completion, an average of 5 years

Study Arms (3)

Healthy Individuals

Procedure: Colon Tissue Biopsy

Individuals with neurologic diseases

Procedure: Colon Tissue Biopsy

Individuals with known or suspected autoimmune diseases

Procedure: Colon Tissue Biopsy

Interventions

Colon Tissue Biopsy PROCEDURE

Colonoscopy and colon tissue biopsy.

Healthy Individuals; Individuals with known or suspected autoimmune diseases; Individuals with neurologic diseases

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants will be individuals who are having screening colonoscopies (+/- upper endoscopies) and those who are willing to have these procedure/s performed for research, and who are willing to donate tissue for research. Healthy individuals, individuals with neurologic diseases, and individuals with known or suspected autoimmune diseases will all be candidates to participate

You may qualify if:

• Age 18 and up
• ONE of the following:
• Recommended to under a screening colonoscopy (+/- upper endoscopy) as part of standard of care. This includes healthy individuals as well as those with neurologic and/or autoimmune diseases. OR
• Willing to undergo research colonoscopy (+/- upper endoscopy) for research

You may not qualify if:

• Currently pregnant. Women of childbearing potential would perform a point of care urine pregnancy test prior to colonoscopy/endoscopy.
• Known or suspected, chronic inflammatory gastrointestinal disease (e.g. inflammatory bowel disease)
• Known, acute or chronic infections
• Systemic antibiotic (PO or IV) use within 3 months of colonoscopy
• Systemic corticosteroid use (equivalent of prednisone 10 mg per day or higher for \>5 days) within 2 weeks of colonoscopy
• Malignancy, diagnosed or treated within the last 5 years
• Probiotic use within 2 weeks of procedure
• History of major GI surgery (e.g. colon resection, gastric bypass)
• Bleeding disorder, or on anticoagulant medication
• Other medical condition that, in the judgement of the investigator, would lead to higher-than-expected risks of biopsy
• Allergy to MAC anesthesia or other drugs used pursuant to standard of care for biospecimen collection

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale MS Clinic

North Haven, Connecticut, 06473, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Colon biopsies blood

MeSH Terms

Conditions

Multiple Sclerosis; Parkinson Disease; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Erin Longbrake

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Marques

CONTACT

2032876100; cynthia.marques@yale.edu

Dimitri Duvilaire

CONTACT

2032876100; dimitri.duvilaire@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: March 26, 2024
• Study Start: August 2, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)