Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Modified gut microbiota composition
研究概览
简要总结
In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
e
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
- •Over 18 years
- •Active newly diagnosed colitis (Mayo score <11)
- •Signed informed consent
排除标准
- •Fulminant severe colitis (Mayo score 11-12 or Truelove and Witts criteria)
- •Gastrointestinal infection
- •Pregnancy
- •Antibiotic therapy at the baseline
- •On-going probiotic medication
- •Unable to provide signed informed consent
研究组 & 干预措施
The control group
The control group will be given colored water at same timepoints
干预措施: Colored water (Other)
The study group
The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit
干预措施: Fecal microbiota transplantation (Other)
结局指标
主要结局
Modified gut microbiota composition
时间窗: at week 12
Increased species richness and alfa-diversity
次要结局
未报告次要终点
研究者
Kimmo Salminen
MD, PhD, Specialist in Gastroenterology
Turku University Hospital