NCT06329453 · Yale University
Intestinal Immunity in Neurologic Disease
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Colon Tissue Biopsy
Colonoscopy and colon tissue biopsy.
Primary outcome measures
Characterization of immune cells from the gastrointestinal mucosa
Time frame: Through study completion, an average of 5 years
Gastrointestinal mucosa cells will be characterized using sRNA measured through high-throughput sequencing with quantitative polymerase chain reaction (qPCR) validation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- North Haven, Connecticut
Collaborators
National Institutes of Health (NIH), Chan Zuckerberg Biohub, The Brain Research Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations