NCT01193894已完成2 期
A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis
Nordisk Rebalance A/S1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2010年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Development in Simple Clinical Colitis Activity Index (SCCAI) score
研究概览
简要总结
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Active ulcerative colitis (SCCAI =>5 and <=11)
- •Access to Internet
排除标准
- •Stoma or intestinal resections
- •Recent changes in UC medication
- •Treatment with antibiotics
- •Celiac disease
- •Lactose malabsorption
结局指标
主要结局
Development in Simple Clinical Colitis Activity Index (SCCAI) score
时间窗: 8 and 16 weeks
Clinical significant difference (\>1.5) in course of SCCAI score between the two intervention groups
次要结局
- Reduction in SCCAI score(8 and 16 weeks)
- Clinical remission(8 and 16 weeks)
- Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability(20 weeks)
研究者
研究点 (1)
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