NCT04883840终止2 期
Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 177
- 试验地点
- 3
- 主要终点
- Significant change in gastrointestinal microbiome composition
研究概览
简要总结
- Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2)
- Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis and Crohn's disease patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Rosuvastatin 10mg (Drug)
Rosuvastatin 10 mg
Experimental
干预措施: Rosuvastatin 10mg (Drug)
结局指标
主要结局
Significant change in gastrointestinal microbiome composition
时间窗: 8 weeks
Change away from dysbiotic enterotype to eubiotic one when taking IMP
次要结局
- UC Mayo Score / CDAI(8 weeks)
研究者
研究点 (3)
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