Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of patients with different viral load in the colonic mucosa
研究概览
简要总结
Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. In previous studies, the active role of cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex) together with that of CMV in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe UC flare-up (Mayo score >6 with endoscopic score higher or equal than 2). The viral load will also be correlated to the Mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •Voluntary to participate to the study
- •Flare-up of ulcerative colitis with Mayo score >6
- •Ability to receive steroid or anti-TNF therapy
- •Agree the rectosigmoidoscopy and the therapies
排除标准
- •Age <18 years
- •Pregnancy
- •Disagree the rectosigmoidoscopy or the therapies
- •Participation to the evaluation of a new therapy
- •Colectomy (partial or total)
- •Contraindication of steroid or anti-TNF therapy
- •Anticoagulant drugs
研究组 & 干预措施
Patients with ulcerative colitis
Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample.
干预措施: rectosigmoidoscopy (Procedure)
Patients with ulcerative colitis
Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample.
干预措施: biopsies (Biological)
Patients with ulcerative colitis
Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample.
干预措施: blood sample (Biological)
结局指标
主要结局
Number of patients with different viral load in the colonic mucosa
时间窗: day 1
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa
次要结局
- Correlation of the different viral loads with the steroid treatment response(up to 24 months)
- Correlation of the different viral loads with the anti-TNF treatment response(up to 24 months)
- Correlation of the different viral loads with the Mayo endoscopic score(Day 1)