Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Enteral Nutrition Tolerance
研究概览
简要总结
Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that primarily affects the movement of the intestines, leading to symptoms that resemble a true bowel obstruction but without a physical blockage. This condition is characterized by impaired motility of the gastrointestinal tract, which can result in severe symptoms and complications. In previous studies, the investigator found that sequential microbiota transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building on this foundation, the current study further investigates the effects of sequential interventions involving intestinal cleansing, small intestine bacterial treatment, fecal microbiota transplantation, and nutritional therapy on the short-term and long-term clinical symptom improvement in patients. Additionally, the investigator aim to elucidate the changes in gut microbiota phenotypes before and after treatment.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged over 18 years old;
- •met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction;
- •can tolerate nasojejunal tube and complete full course of FMT treatment;
- •the clinical data are relatively complete and there is follow-up available for evaluation
排除标准
- •accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
- •associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment
结局指标
主要结局
Enteral Nutrition Tolerance
时间窗: 8 weeks
the maximal amount of enteral nutrition allowed daily
次要结局
- Nutrition Status(52 weeks)
研究者
Huanlong Qin
Dean of the hospital
Shanghai 10th People's Hospital
