Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- the tolerance of enteral nutrition (EN) through nasojejunal tube
研究概览
简要总结
Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with life-threatening condition, and it is often related with bacterial overgrowth. Fecal microbiota transplantation (FMT) results in restoration of the normal intestinal microbial community structure. The investigators planned to observe the efficacy of FMT in the treatment of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and gastrointestinal quality-of-life index(GIQLI) were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients had to have a firm diagnosis diagnostic criteria for CIPO proposed by Ministry of Health, Labour, and Welfare, including documented pathological bowel dilatation on imaging in the absence of mechanical obstruction.
排除标准
- 未提供
研究组 & 干预措施
FMT
Patients included will receive standard FMT, and then will be followed up for 8 weeks.
干预措施: fecal microbiota transplantation (Procedure)
结局指标
主要结局
the tolerance of enteral nutrition (EN) through nasojejunal tube
时间窗: 8 weeks
We defined feeding intolerance (FI) as inability to deliver the amount of nutrient as a proportion of 'energy requirements', with values of 80% chosen, or a certain amount (750ml) per 24h.
the time oral intake started
时间窗: 8 weeks
The time when oral intake (both fluids and solid food) started was noted.
次要结局
- symptomatic relief(8 weeks)
- scoring evaluation of abdominal CT(8 weeks)
研究者
Ding Chao
MD candidate
Jinling Hospital, China