NCT00184171终止不适用
Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 9
- 主要终点
- Symptoms: Stool frequency and consistency
研究概览
简要总结
The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis
详细描述
This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).
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
- 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
- •Microscopic colitis verified with biopsies from the colon
- •Symptoms to such an extent that treatment is indicated
- •Age > 17 years
- •Informed consent
排除标准
- •Previous treatment with any of the investigational drugs
- •Patients treated with ketoconazole
- •Pregnant and breast-feeding females
研究组 & 干预措施
Budesonide
Experimental
Budesonide 9mg
干预措施: Budesonide (Drug)
bismuth
Experimental
Bismuth mixture
干预措施: Bismuth (Drug)
Fiber
Sham Comparator
Fiber preparation
干预措施: Fiber (Drug)
结局指标
主要结局
Symptoms: Stool frequency and consistency
时间窗: 2001 - 2011
September 2010: Patient's enrollment completed. Data analysis ongoing.
次要结局
- Histological findings in biopsies from colon(2001 - 2011)
研究者
研究点 (9)
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Unknown
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