The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis - A Case Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI)
研究概览
简要总结
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.
详细描述
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Ulcerative Colitis (UC)
- •SCCAI between 4 and 10 at inclusion
- •On a stable dose of 5-aminosalicylic acid (5-ASA) or without current treatment.
- •Previous treatment with glucocorticoids, thiopurines and/or biological treatment was accepted.
- •Fecal Calprotectin > 250 mg/kg
- •Colonoscopy performed within the last 3 years
- •Capable of writing and speaking Danish
- •Attending regular follow-ups by a specialist in gastroenterology.
排除标准
- •Biological treatment within the last four weeks
- •Treatment with antibiotics within 48 hours before intervention
- •Alcohol use above current Danish guidelines (14 units/week for men and 7 units/week for women)
- •Pregnancy or planned pregnancy
- •Active cancer disease
- •Medical treatment of mental disorder
- •Other chronic gastroenterological disorder besides UC, Irritable Bowel Syndrome (IBS) or Reflux-disease.
研究组 & 干预措施
FMT treated patients
Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily.
干预措施: Fecal Microbiota Transplantation Capsules (Other)
结局指标
主要结局
Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI)
时间窗: Baseline, 2,8,16 and 24 weeks
Simple Colitis Clinical Activity Index (SCCAI)
次要结局
- Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity(Baseline)
- Fecal microbiota biodiversity in fecal donors(At donor inclusion)
- Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline(8, 16 and 24 weeks)
- Changes in Fecal Calprotectin in the active treatment period and follow-up period(Baseline, 8,16 and 24 weeks)
- Changes in patient reported quality of life: IBDQ(Baseline, 8, 16 and 24 weeks)
研究者
Alice Højer Christensen
Principal Investigator, MD, Ph.d., Senior Specialist in Medical Gastroenterology
Aleris-Hamlet Hospitaler København