Inflammatory Bowel Diseases (IBD), Ankylosing Spondylitis (AS)
Conditions
Keywords
intraepithelial lymphocytes (IEL), microbiome, colon mucosa
Brief 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.
Detailed description
Changes in human gut bacteria has been shown in patients with autoimmune diseases, such as inflammatory bowel diseases (IBD). The gut flora in ankylosing spondylitis (AS), an arthritis that can occur with IBD, has not been well studied. The immune cells in the colon directly interface with bacteria and may be influenced by them. The interactions between the colon immune system, bacteria and autoimmunity hasn't been studied. The study goal is to specifically study the link between bacteria, the colonic immune system, and the autoimmune diseases of AS and IBD. This will be done by collecting clinical data by questionnaires, blood samples, colonic tissue during endoscopy, and microbiome data in subjects with IBD, AS, and controls.
Interventions
PROCEDUREPinch biopsies
Biopsies obtained during colonoscopy or flexible sigmoidoscopy.
PROCEDUREFlexible sigmoidoscopy
Offered to subjects with ankylosing spondylitis who do not meet criteria for colonoscopy
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Colorado, Denver
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IEL characteristics in IBD, AS, and healthy controls | 1 hour after colonoscopy | The primary goal for this measure will be to demonstrate characteristics of IEL (intraepithelial lymphocytes) subtypes of healthy individuals and compare those with AS or IBD. IEL characteristics will be based on cell marker outcomes using flow cytometry for CD3, CD4, CD8α, CD8β, CD44, CD45, CD62L, CD69, CD103, TCRαβ, and TCRγδ. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome Differences in IBD, AS, and healthy controls | 1 hour after colonoscopy | The primary hypothesis is that the microbiome population will differ between controls, IBD, and AS; outcomes for this hypothesis will include relative abundance (RA) of individual bacterial species and the Shannon Index for community diversity. |
| Microbiome changes are reflected in IELs | 1 hour after colonoscopy | The primary hypothesis is that dysbiosis will be reflected in the IEL populations in AS and IBD by having a different predominant phenotype (as seen by cell markers) compared to healthy controls; the investigators will evaluate the IEL outcomes determined to be significantly different among AS, IBD, and healthy controls as identified in Outcome 1 (Primary Outcome). |
Countries
United States
Outcome results
None listed