Intestinal Immunity in Neurologic Disease

Launched by YALE UNIVERSITY · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Intestinal Immunity in Neurologic Disease," is looking into how immune cells in the gut may impact diseases like Multiple Sclerosis, Parkinson's Disease, and REM Sleep Behavior Disorder. Researchers aim to understand the role these immune cells play in autoimmune and neurological conditions. The study is currently recruiting participants aged 18 and older, including healthy individuals and those with the mentioned diseases, who are recommended to have a colonoscopy as part of their regular care or are willing to participate in the research.

If you decide to participate, you'll undergo a colonoscopy, which is a procedure that allows doctors to examine your intestines. Certain health conditions, such as pregnancy, chronic gut diseases, recent infections, or specific medication use can prevent someone from joining the study. This trial is an opportunity to help researchers learn more about the relationship between gut health and neurological diseases, potentially leading to better treatments in the future.

Gender

ALL

Eligibility criteria

• 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