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临床试验/NCT03787771
NCT03787771招募中不适用

The Fecal Microbiota Transplantation Registry

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Set up a FMT registry

研究概览

简要总结

The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder.

Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies[8]. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A FMT registry is required to explore the relationship between disease prognosis and intestinal microbiota.

详细描述

The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder. A research using gene-sequencing technique showed an abnormal microbiota composition such as specific group of Escherichia coli and decreased diversity of intestinal microbiota in individuals with Inflammatory Bowel Disease (IBD) [2-4]. These microbiotas may stimulate the production of cytokine and chemokines that leads to the mucosal inflammatory activity[5]. Gut microbiota may also link with the development of obesity and diabetes by affecting host fat storage and increasing energy harvest from the diet[6-7].

Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies8. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A recent clinical study evaluated the efficacy of FMT in active Ulcerative Colitis. It showed one-forth cases of the FMT group were in UC remission and an increase in diversity of microbiota composition. However, these results were dependent on the donor[9].

There will be increasing use of FMT in clinical practice, as well as more studies investigating the effectiveness of FMT on other diseases in the future. However, as an emerging procedure, there is currently no registry system to track patient safety information of FMT. It is also equally important to promote scientific investigation around gut microbiome. Therefore, the investigators aim to establish a FMT registry platform to collect clinical data and specimen from FMT recipients and donors. This registry is initiated Hong Kong, and will be expanded to other part of Asia.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent obtained
  • Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research (FMT recipents)
  • Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research. Subjects who failed screening will also be recruited. (FMT donors)

排除标准

  • 未提供

结局指标

主要结局

Set up a FMT registry

时间窗: 10 years

Set up a registry of FMT to collect data such as demographics, past medical history, surgery, severity of disease indicated for FMT cases

次要结局

  • Factors associated with successful FMT(10 years)
  • Characterize FMT stool donors and other gut-related microbiota products(10 years)
  • Future research studies(10 years)
  • Promoting scientific investigation in FMT(10 years)
  • Patient outcome of FMT(10 years)
  • FMT in Asia(10 years)
  • Developing Biobank of FMT(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siew Chien NG

Professor

Chinese University of Hong Kong

研究点 (1)

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