Intestinal Immunity in Neurologic Disease
Recruiting · NCT06329453 · Observational (researchers observe without assigning treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Colon Tissue Biopsy
What this trial 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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age 18 and up
- NE 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 it is running
1 location listed across 1 US state.
- Yale MS Clinic - North Haven, Connecticut, United States