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)

Yale MS Clinic

North Haven, Connecticut, United States

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NCT06329453


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