Intestinal Immunity in Neurologic Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 99 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how immune cells in the gut work and how they may affect nerve and brain diseases and autoimmune diseases, where the body attacks itself. It is for adults age 18 and older, including healthy people and people with these diseases, who will have a colonoscopy for routine care or research.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be age 18 or older and meet one of the two conditions below.
- A doctor has recommended a screening colonoscopy as part of your usual care. This camera test looks inside your large intestine.
- Or, you are willing to have a colonoscopy for research. Either option may also include an upper endoscopy, a camera test of your upper digestive tract.
Who can't join
- You are pregnant. People who could become pregnant will have a urine pregnancy test before the procedure.
- You have or may have a long-term gut disease that causes swelling, such as inflammatory bowel disease, or you have a known short-term or long-term infection.
- You took antibiotics by mouth or through a vein within 3 months before the colonoscopy.
- Within 2 weeks before the colonoscopy, you used a steroid medicine affecting the whole body at a dose equal to at least 10 mg of prednisone daily for more than 5 days.
- You had cancer diagnosed or treated in the past 5 years, or used probiotics within 2 weeks before the procedure.
- You have had major digestive tract surgery, such as removal of part of the colon or gastric bypass.
- You have a bleeding disorder, take blood thinners, or have another condition that the study doctor thinks makes taking a tissue sample too risky.
- You are allergic to MAC anesthesia, medicine used to keep you comfortable during the procedure, or other medicines used to collect samples.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
CT
- Yale MS Clinic · North Haven, CT 06473Cynthia Marques · Study contact · 2032876100 · cynthia.marques@yale.eduDimitri Duvilaire · Study contact · 2032876100 · dimitri.duvilaire@yale.eduErin Longbrake, MD · Principal investigatorMore trials in North Haven