Regulation of Mucosal Healing in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in expression levels of Ki67
研究概览
简要总结
The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing.
详细描述
Induction of mucosal healing in inflammatory bowel disease (IBD) is associated with reduced hospitalizations, surgeries, and reduced cancer risk. However, previous studies have shown that 54-69% of ulcerative colitis (UC) patients fail to heal ulcers after several weeks of treatment, and roughly half do not maintain remission at one year. The single most important factor in preventing severe medical consequences, like colon removal surgery or cancer, is treatment to completely heal the top layer of the intestine as quickly as possible. Healing is a complex process and the dysfunction observed in colitis can only be fully understood by comparison to healing in non-IBD patients.
This is a prospective trial involving three groups of patients: 1) IBD patients with active disease, newly treated with anti-TNF therapy (biologic failure or naïve); 2) non-IBD patients with rheumatoid/psoriatic arthritis who are receiving anti-TNF therapy, and 3) healthy control patients. Biopsies will be collected at baseline during standard of care endoscopy and at a follow-up research endoscopy.
This study will probe mechanisms of ulcer healing by analyzing gene expression patterns and mitochondrial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Classified in an anesthesia risk group, ASA Class =4
- •History of bleeding diathesis or coagulopathy
- •Stroke or transient neurological attack with the last 6 months
- •Receiving anticoagulants or anti-platelet medications other than low-dose aspirin
- •Receiving steroid therapy or metformin
- •HIV positive
- •Incarceration
- •History of total proctocolectomy
- •History of system chemotherapy within 18 months
- •Uncontrolled intercurrent illness
结局指标
主要结局
Change in expression levels of Ki67
时间窗: 35 days
Relative expression of Ki67 alpha (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Change in mitochondrial DNA copy number
时间窗: 35 days
Mitochondrial DNA copy number will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Change in expression levels of cMyc
时间窗: 35 days
Relative expression of cMyc (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Change in expression levels of PGC-1 alpha
时间窗: 35 days
Relative expression of PGC-1 alpha (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Number of visible ulcers
时间窗: 1 day (at follow-up visit)
The number of visible ulcers will be assessed during the follow-up endoscopy for healthy patients and rheumatoid/psoriatic arthritis patients only.
次要结局
- Change in Mayo Endoscopic Score(35 days)
- Change in Segmental SES-CD Score(35 days)
研究者
Terrence A Barrett
Professor
University of Kentucky