NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Intestinal Immunity in Neurologic Disease

RecruitingN/A

Sponsor: Yale University

Conditions: Multiple Sclerosis, Parkinson Disease, REM Sleep Behavior Disorder

Interventions: Colon Tissue Biopsy

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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

Locations (1)

North Haven, Connecticut, United States