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临床试验/NCT01742754
NCT01742754终止不适用

Evaluation of Durability of Fecal Microbiota Transplantation in Patients With Mild to Moderate Ulcerative Colitis

University of Washington2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
2
主要终点
Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation.

研究概览

简要总结

Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by shifting the recipient's microbiota toward a eubiotic microbial community that resists colonization by pathogenic organisms or decreases its inherent inflammatory properties. Several studies now report its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success. This is corroborated by several lines of evidence suggesting dysbiosis plays an important role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic or immunologic factors in UC leading to selection pressure preventing a change in the microbiota. As an initial step into investigating the potential efficacy of stool transplants for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mild to moderate UC.

排除标准

  • Antibiotic exposure in the last 3 months.
  • Biologic or immunomodulatory therapy within the last 3 months.
  • Corticosteroid therapy or probiotics within the last 2 weeks.
  • Severely active disease (defined as Mayo scores of 10 or greater, or patients with endoscopic disease activity scores of 3 or greater).

结局指标

主要结局

Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation.

时间窗: 4 weeks

Metagenomic shotgun sequencing using Iluminia technology will be used to evaluate for engraftment. Metagenomic data will be analyzed using CompareReads. A % similarity to the recipient \> than % similarity to the donor will be defined as engraftment.

次要结局

  • Endoscopic remission at 4 weeks.(4 weeks)
  • Durability of Fecal Microbiota Transplantation at 12 weeks(12 weeks)
  • Engraftment of fecal microbiota transplantation at 7 days.(7 days)
  • Clinical remission at 12 weeks.(12 weeks)
  • Number of patients with worsened disease.(4 weeks.)
  • Clinical remission at 4 weeks.(4 weeks)
  • Number of adverse events.(12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy Zisman

Assistant Professor of Medicine, Medicine/Division of Gastroenterology

University of Washington

研究点 (2)

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