Prototype Study on Association Between Clinical, Laboratory and Thermographic Findings in Patients With Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in abdominal surface temperatures in ulcerative colitis patients at 6 months
研究概览
简要总结
Ulcerative colitis represents a chronic condition occurring in relapsing and remitting fashion with uncertain outcome and requires lifelong treatment with considerable side effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or laboratory (C - reactive protein, fecal calprotectin) give an insight into disease activity but are possibly associated with significant discomfort for the patient and / or increased risk of irradiation and potential allergic reactions on contrast agents. For that reason there is a need for a noninvasive, biologically inert method for evaluation of disease activity in inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The aim of this study is to find potential link between pathological thermographic signs and endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients with active and extensive ulcerative colitis.
详细描述
Hypothesis
Documenting pathological thermographic signs in patients with extensive ulcerative colitis investigators will demonstrate pathological thermography criteria that correlate with standard inflammatory markers such as Mayo endoscopic subscore (ESS), CRP and calprotectin in patients with ulcerative colitis.
Aims: The aim of this study is to record abdominal thermographic images of patients with active ulcerative colitis (UC), to create interpretational thermographic criteria for these images and to compare them to abdominal infrared (IR) images of healthy volunteers. Furthermore, investigators intend to correlate these criteria with standard markers of inflammation such as CRP and calprotectin in patients with UC at the beginning of treatment and at the end.
Materials and methods
For the purpose of this work, 36 patients with extensive UC and 30 healthy individuals will be put throe thermographic imagining, have their stool tested for calprotectin and their blood for CRP. In addition, patients with UC will receive colonoscopy evaluations.
Expected scientific contribution: The results of this paper would give an additional contribution to existing tools for pursuing ulcerative colitis activity thus demonstrating the potential of thermography as a complementary method to standard methods in assessing disease activity. Establishing diagnostic criteria for this method would be a good addition to present clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Endoscopic diagnosis of active extensive ulcerative colitis
- •Stool Calprotectin > 150 mcg/g
- •CRP > 5 mg/L
- •Signed informed consent form
排除标准
- •Inability to preform total colonoscopy
- •Marked abdominal comorbidities
- •Prior abdominal surgery
结局指标
主要结局
Change in abdominal surface temperatures in ulcerative colitis patients at 6 months
时间窗: Six months
Patients will be treated with mesalamin, corticosteroids or biologic therapy according to disease status during 6 months. Abdominal temperatures (maximal, minimum and average temperatures measured in Celsius) recorded by a thermographic camera will be acquired at enrollment and after 6 months of therapy.
次要结局
- Correlation of abdominal surface temperatures between ulcerative colitis patients and healthy volunteers.(Baseline and after 6 months)
- Correlation of abdominal surface temperature values with clinical markers of inflammation in ulcerative colitis.(Baseline and after 6 months)
- Correlation of abdominal surface temperature values with fecal markers of inflammation in ulcerative colitis.(Baseline and after 6 months)
- Correlation of abdominal surface temperature values with serum markers of inflammation in ulcerative colitis.(Baseline and after 6 months)
- Correlation of abdominal surface temperature values with endoscopic markers of inflammation in ulcerative colitis.(Baseline and after 6 months)
研究者
Tonći Božin
Gastroenterology Resident
University Hospital Dubrava