Actively Recruiting
Intestinal Immunity in Neurologic Disease
Led by Yale University · Updated on 2026-05-27
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how immune cells in the gastrointestinal (GI) tract affect autoimmune and neurologic diseases like multiple sclerosis, Parkinson's disease, and REM sleep behavior disorder. This observational cohort study aims to provide new insights by using advanced single cell technologies to study immune cells and microbes in specific gut areas, which may change how these neurologic diseases are understood. The study includes healthy individuals and those with neurologic or autoimmune diseases to compare immune system features across age groups. Participants will undergo colonoscopy with the option of upper endoscopy to collect tissue biopsies from the GI mucosa. Some participants will have these procedures as part of their standard care, while others will consent to have them done for research purposes. The study specifically includes age-matched healthy controls to account for changes in immune function that occur with aging. The collected biopsies will be analyzed to characterize immune cells and the microbiome at different gut sites. Throughout the study, which is expected to last about five years, researchers will evaluate immune cell profiles, spatial transcriptomics of intestinal tissue, and the microbiome composition. Participants will provide tissue samples during colonoscopy procedures, and data will be collected to understand the immune environment in the gut. This research is observational, so no treatments are given, and participants will continue their usual care as recommended by their doctors.
CONDITIONS
Brief Title
Intestinal Immunity in Neurologic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and up
- Scheduled for screening colonoscopy (+/- upper endoscopy) as part of standard care or willing to undergo colonoscopy (+/- upper endoscopy) for research
- Includes healthy individuals and those with neurologic and/or autoimmune diseases
You will not qualify if you...
- Currently pregnant
- Known or suspected chronic inflammatory gastrointestinal disease (e.g. inflammatory bowel disease)
- Known acute or chronic infections
- Systemic antibiotic use within 3 months of colonoscopy
- Systemic corticosteroid use (prednisone 10 mg/day or higher for >5 days) within 2 weeks of colonoscopy
- Malignancy diagnosed or treated within last 5 years
- Probiotic use within 2 weeks of procedure
- History of major gastrointestinal surgery (e.g. colon resection, gastric bypass)
- Bleeding disorder or on anticoagulant medication
- Other medical condition increasing biopsy risks as judged by investigator
- Allergy to anesthesia or drugs used during biospecimen collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Day of procedure
Participants undergo colonoscopy and tissue biopsy as part of standard care or research to collect gastrointestinal mucosa samples.
1 visit (in-person) for colonoscopy and biopsy
Duration - Up to 5 years
Participants are followed over several years to characterize immune cells and microbiome from collected gastrointestinal tissue samples.
Follow-up assessments as needed, visit frequency varies
Trial Site Locations
Total: 1 location
1
Yale MS Clinic
North Haven, Connecticut, United States, 06473
Actively Recruiting
Research Team
C
Cynthia Marques
D
Dimitri Duvilaire
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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