Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- complete steroid reduction
研究概览
简要总结
The purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis.
The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus layer. The background of the study is the finding, that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls and patients with Crohn´s disease. The content was measured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.
详细描述
Design: Prospective, randomized, placebo-controlled, double-blinded study.
Population: 60 patients with chronic active ulcerative colitis and steroid dependency
Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or more, steroid dependent course since at least 4 months.
Main criteria: complete steroid reduction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Letter of Content
- •diagnosis of ulcerative colitis (clinical, endoscopic and histologic evidence)
- •chronic active and steroid dependent course over at least 4 months (CAI > 4, EAI > 4)
排除标准
- •infectious colitis
- •toxic megacolon
- •ulcerative proctitis or less than 20cm inflamed
结局指标
主要结局
complete steroid reduction
次要结局
- remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis