Expired Study
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Denver, Colorado


Purpose:

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.


Study summary:

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.


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. 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 a diagnosis of sacroiliitis AS: Inclusion Criteria: - Diagnosed with an axial spondyloarthritis (SpA) by a rheumatologist - - Meet the Assessment of SpondyloArthritis international Society (ASAS) axial spondyloarthritis (SpA) criteria 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 dificile within the past 3 months - A known history of idiopathic macroscopic or microscopic colitis


NCT ID:

NCT02389075


Primary Contact:

Principal Investigator
Kristie Kuhn, MD, PhD
University of Colorado, Denver


Backup Contact:

N/A


Location Contact:

Denver, Colorado
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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