Fecal Microbiota Transplantation for Constipation With Difficult Defecation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- stool consistency
研究概览
简要总结
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation.
详细描述
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation. Patients underwent single FMT in this study were divided into hard-stool group and loose-stool group. All patients were assessed before FMT and during 12-week follow-up 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 14-80 years old;
- •difficult defecation with more than six months (a. straining during defecation; b. sensation of incomplete evacuation; c. sensation of anorectal blockage; d. manual maneuvers to facilitate defecation).
排除标准
- •difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders);
- •with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD);
- •pregnant or breast-feeding women;
- •infection with pathogenic bacteria. Enrolled patients were divided into hard-stool group and loose-stool group according to their stool patterns. All patients were followed up for 12 weeks.
研究组 & 干预措施
Fecal microbiota transplantation (FMT)
Patients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT.
干预措施: Fecal Microbiota suspension (Drug)
结局指标
主要结局
stool consistency
时间窗: 12 weeks
The category of stool consistency score based on the BSS (Bristol Stool Form Scale)
defecation frequency
时间窗: 12 weeks
frequency of defecation per week
次要结局
未报告次要终点
研究者
Faming Zhang
Associate professor, Gastroenterology
The Second Hospital of Nanjing Medical University