NCT05998174尚未招募早期 1 期
Faecal Microbiota Transplantation for Microscopic Colitis
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Treatment effect
研究概览
简要总结
A pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of microscopic colitis
- •Date of diagnosis/histological confirmation < 12 months
- •Active disease according to Hjortswang's criteria
排除标准
- •Diagnosed with ulcerative colitis or Crohn's disease
- •Diagnosed with celiac disease
- •Active gastrointestinal infection
- •Previous bowel resection of bowel (except appendectomy)
- •Previous cholecystectomy
- •Treatment with systemic steroid within 4 weeks, including budesonide
- •Antibiotics 3 months prior
- •Severe immunodeficiency,
- •Pregnancy, planned pregnancy and breastfeeding
- •Treatment with constipants such as psyllium, loperamide, bile binders, opium drops or codeine up to 2 weeks before inclusion and during participation
结局指标
主要结局
Treatment effect
时间窗: 3 weeks
Proportion of participants in remission
次要结局
未报告次要终点
研究者
Sigen Wildt
Consultant, MD, ph.d
Hvidovre University Hospital
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