The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- IEL characteristics in IBD, AS, and healthy controls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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 difficile within the past 3 months
- •A known history of idiopathic macroscopic or microscopic colitis
结局指标
主要结局
IEL characteristics in IBD, AS, and healthy controls
时间窗: 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.
次要结局
- Microbiome Differences in IBD, AS, and healthy controls(1 hour after colonoscopy)
- Microbiome changes are reflected in IELs(1 hour after colonoscopy)