NCT06329453 Intestinal Immunity in Neurologic Disease
| NCT ID | NCT06329453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-02 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-08-02 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Erin Longbrake
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06329453 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06329453 currently recruiting?
Yes, NCT06329453 is actively recruiting participants. Contact the research team at cynthia.marques@yale.edu for enrollment information.
Where is the NCT06329453 trial being conducted?
This trial is being conducted at North Haven, United States.
Who is sponsoring the NCT06329453 clinical trial?
NCT06329453 is sponsored by Yale University. The principal investigator is Erin Longbrake at Yale University. The trial plans to enroll 100 participants.
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