跳至主要内容
临床试验/NCT03949257
NCT03949257Unknown不适用

Dynamic Changes of Gut Microbiota in Patients With Ulcerative Colitis After Fecal Transplantation

The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
changes of gut microbiota

研究概览

简要总结

A prospective study to investigate the dynamic changes of gut microbiota through colonic transendoscopic enteral tubing in patients with ulcerative colitis after fecal microbiota transplantation.

详细描述

Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. This tube also can serve as a medium for collecting gut microbiota. Fecal Microbiota Transplantation (FMT) was identified to be promising for ulcerative colitis (UC). This study aims to investigate the dynamic changes of gut microbiota in patients with UC after FMT.

研究设计

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

入排标准

年龄范围
7 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients were diagnosed with mild or moderate ulcerative colitis.
  • •Patients need colonic TET and FMT
  • •Must be able to colonic TET and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.
  • •Age > 7 years old and < 65 years old

排除标准

  • •gut microbiota was not collected successfully

研究组 & 干预措施

colonic TET and FMT

Experimental

gut microbiota will be collected through the colonic TET after FMT

干预措施: colonic transendoscopic enteral tubing (Device)

结局指标

主要结局

changes of gut microbiota

时间窗: 7 days

gut microbiota will be collected through the colonic TET

次要结局

  • frequency of defecation(7 days)

研究者

发起方
The Second Hospital of Nanjing Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验