RecruitingNCT06329453
Intestinal Immunity in Neurologic Disease
Sponsor
Yale University
Enrollment
100 participants
Start Date
Aug 2, 2022
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria4
- 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 Criteria11
- 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
Interventions
PROCEDUREColon Tissue Biopsy
Colonoscopy and colon tissue biopsy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06329453
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