NCT01961492撤回不适用
Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Activity of ulcerative colitis
研究概览
简要总结
The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative 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
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed
排除标准
- •severe ulcerative colitis (PUCAI > 65)
研究组 & 干预措施
Fecal microbiota transplantation
Active Comparator
A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment
干预措施: Fecal microbiota transplantation (Other)
Standard medical treatment
No Intervention
Standard medical treatment as recommended by the ECCO Guidelines of UC therapy.
结局指标
主要结局
Activity of ulcerative colitis
时间窗: Within 1 year after the intervention
Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.
次要结局
- Adverse events(Within 1 year after the intervention)
- Colonic inflammation(Within 1 year after the intervention)
研究者
Marko Kalliomäki
Specialist
Turku University Hospital
研究点 (2)
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