EUCTR2006-004162-13-DE进行中（未招募）1 期
Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients
Charité Universitätsmedizin, Campus Charité Mitte0 个研究点目标入组 40 人开始时间: 2006年10月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Signed informed conssent.
- •- 18-70 years of age.
- •- Active left-sided UC or CD with inflammation within 40 cm ab ano.
- •- Clinical and histological confirmed diagnosis.
- •- Mild to moderate disease activity:
- •UC: CAI >= 5 and <=10
- •CD: CDAI >= 220 and <=350
- •- Enhanced mucosal biofilm, i.e., >= 0.6x10 to the 10th germs/ml mucus
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Secondary serious illness,
- •- Positive stool test for disease causing germs,
- •- Therapy with mesalazine within 4 weeks and/or antibiotisc within 12 weeks prior
- •- Serum creatinine > 1.5 mg/dl and creatinine clearance <60mml/min per 1.73
- •squaremeter
- •- Serum transaminases (ALT or AST) or alkaline phosphatase > 2x ULN.
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