The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis (NCT02389075) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis
United States129 participantsStarted 2015-03
Plain-language summary
This study plans to learn more about the relationship between systemic autoimmune disease, such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon, and the changes in colon tissue.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Healthy Controls
Exclusion criteria:
* Pregnancy
* Use of antibiotics within the past 14 days†
* Current diagnosis of colon cancer
* Diagnosis of celiac disease
* Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
* Chemotherapy or radiation therapy for any malignancy within the past year
* Daily use of aspirin or NSAIDs with inability to hold the drug 7 days before and after the procedure
* Current use of anticoagulation (LMWH,warfarin,etc.)
* A diagnosis of HIV
* Clostridium difficile within the past 3 months
IBD
Inclusion Criteria:
* Established IBD (either Crohn's disease or ulcerative colitis)
* Suspected to have IBD by a gastroenterologist and undergoing diagnostic endoscopy and biopsy. Diagnosis will be confirmed on biopsy and patients who are negative will be considered for controls based on the pathology found.
Exclusion Criteria:
* Pregnancy
* Use of antibiotics within the past 14 days
* Current diagnosis of colon cancer
* Diagnosis of celiac disease
* Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
* Chemotherapy or radiation therapy for any malignancy within the past year
* Daily use of aspirin or NSAIDs with inability to hold the drug 7 days before and after the procedure
* Current use of anticoagulation (LMWH, warfarin,etc.)
* A diagnosis of HIV
* Clostridium difficile within the past 3 months
* Evidence of inflammatory spinal or axial arthritis or disease based on chart review such as inflammation seen on radiographs or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IEL characteristics in IBD, AS, and healthy controls