FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Maintenance of remission of ulcerative colitis
研究概览
简要总结
Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.
详细描述
80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).
The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participant and the treating personnel are blinded of the randomization result.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• • Diagnosis of CU based on clinical, endoscopic, and histological findings.
- •Remission assessed by Mayo score (0 to 1) and F-Calpro (<100 ug/g).
- •Availability of consecutive fecal samples during one year after the diagnosis of CU.
- •Availability of blood sample to study the IBD associated genetic background
- •Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
- •18-75 years
排除标准
- •Unable to provide informed consent
- •Need for any antibiotic therapy within 3 months
- •Use of corticosteroids, immunosuppressive or biological medication at the baseline
- •Use of any probiotics
- •Pregnancy
研究组 & 干预措施
FMT
50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum
干预措施: Fecal microbiota transplantation (FMT) (Other)
Placebo
50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.
干预措施: Placebo (Other)
结局指标
主要结局
Maintenance of remission of ulcerative colitis
时间窗: 52 weeks
Endoscopic remission and Mayo-score \< 2
次要结局
未报告次要终点