Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-08-02
2027-08-31
Brief Summary
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Detailed Description
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This is an observational cohort study. Individuals undergoing colonoscopy (+/- upper endoscopy) as a part of standard of care or who consent to have a colonoscopy (+/- upper endoscopy) will be recruited to provide tissue biopsies obtained from the gastrointestinal mucosa. The rationale for including those who are not yet due to have a screening colonoscopy is that for many neurologic diseases (like MS), the disease onset is in adolescence or early adulthood, and the disease is diagnosed in young adults. These individuals would not yet be due to have screening colonoscopies, and yet changes in immune cells within the intestines may be a critical part of disease pathogenesis. This is what the investigators are exploring with this study.
The investigators will need to recruit age matched healthy controls because many features of the immune system change with age; as people get older, the immune system becomes less inflammatory ("immune senescence") and thus it is essential to have age-matched tissues for comparison.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Individuals
Colon Tissue Biopsy
Colonoscopy and colon tissue biopsy.
Individuals with neurologic diseases
Colon Tissue Biopsy
Colonoscopy and colon tissue biopsy.
Individuals with known or suspected autoimmune diseases
Colon Tissue Biopsy
Colonoscopy and colon tissue biopsy.
Interventions
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Colon Tissue Biopsy
Colonoscopy and colon tissue biopsy.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
99 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Erin E Longbrake
Principal Investigator
Principal Investigators
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Erin Longbrake
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale MS Clinic
North Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2000033081
Identifier Type: -
Identifier Source: org_study_id
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