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临床试验/NCT06020365
NCT06020365已完成不适用

Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年1月1日最近更新:
适应症

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

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

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huanlong Qin

Dean of the hospital

Shanghai 10th People's Hospital

研究点 (1)

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