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临床试验/NCT02560727
NCT02560727Unknown不适用

Feasibility, Safety, and Efficacy of Transendoscopic Enteral Tubing in Fecal Microbiota Transplantation

The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
durability of clinical remission

研究概览

简要总结

No technique by placing a tube through anus into cecum for whole colon administration. This study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.

详细描述

The previous reported fecal microbiota transplantation (FMT)through whole colon. delivering ways were involved with upper digestive tract, middle digestive tract and lower digestive tract. FMT via colonoscope is the most common approach, participants have to endure the discomfortable of bowel preparation and colonoscopy, and FMT by colonoscopy was recommended for repeat FMT treatment in short period. Traditional enema infuses bacteria solution into rectal and sigmoid colon but cannot spread to whole colon.No technique by placing a tube through anus into cecum for whole colon administration, which could be maintained for repeat FMTs.To solve these problems, investigators designed a new technique called transendoscopic enteral tubing (TET).the TET tube was fixed at cecum by clips under endoscopy. This study aimed to evaluate the feasibility, safety, and efficacy of TET for FMT via colonic approach.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild to moderate ulcerative colitis (Montreal classification)

排除标准

  • Diagnosed as ulcerative colitis first time.
  • No history of using Biologic, immunomodulatory therapy or corticosteroid therapy.
  • With contraindication of endoscopy.

结局指标

主要结局

durability of clinical remission

时间窗: One year

The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure by TET.Defined as Montreal score S0 (clinical remission)

次要结局

  • Patients with worsened disease(one year)

研究者

发起方
The Second Hospital of Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Faming Zhang

Associate professor, Gastroenterology

The Second Hospital of Nanjing Medical University

研究点 (1)

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