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临床试验/NCT02461199
NCT02461199Unknown不适用

Prospective Observational Study of Fecal Microbiota Transplantation Used to Eradicate Gut-colonizing Multidrug-resistant Bacteria in Patients With Blood Disorders

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Eradication of gut colonizing bacteria as proven by at least two negative stool cultures.

研究概览

简要总结

During this prospective observational study, the investigators collect the information about the outcomes of fecal microbiota transplantation in patients with blood disorders, performed to eradicate gut colonization with multidrug-resistant (MDR) bacteria.

Patients with blood disorders are characterized by poor diversity of gut microbiome, affected by repeated chemotherapy and antimicrobial treatments. This makes them vulnerable to colonization by pathogenic bacteria carrying genes responsible for antibiotic resistance. In case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause severe systemic infections. As the bacteria are secreted with the stool, the colonized patients become an epidemiologic threat to the others.

Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of relapsed and refractory Clostridium difficile infection and became a standard treatment. In home institution, the investigators use FMT not only in case of Clostridium difficile colitis, but also in case of gut colonization with multidrug-resistant (MDR) bacteria. This is based on assumption that physiological gut flora may outcompete the pathogenic bacteria similarly as in case of Clostridium difficile and lead to loss of colonization. The procedure is performed in all patients colonized, who qualify according to listed inclusion and exclusion criteria .

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Age >18 y
  • Carrier status of MDR bacteria in stool: Klebsiella pneumoniae resistant to carbapenems, Pseudomonas aeruginosa resistant to carbapenems, Enterococcus faecalis VRE, Enterococcus faecium VRE, Enterobacter cloacae KPC+ or other MDR species documented by at least two stool cultures
  • Blood neutrophil count > 500/uL on the day of fecal microbiota transplantation

排除标准

  • Inability to obtain informed consent and lack of consent
  • Blood neutrophil count <500/uL on the day of fecal microbiota transplantation or expected decrease to the mentioned number within 2 consecutive days
  • Intensive, myelosuppressive chemotherapy (e.g. DHAP, ICE, ESHAP, HD-Cy, HD-Ara-C, DA, conditioning before allogeneic stem cell transplantation, BEACOPP) planned within 2 consecutive days
  • Patients up to 1 month after hematopoietic stem cell transplantation
  • Clinical signs of mucositis
  • Severe liver failure
  • Patients undergoing intensive antimicrobial treatment

结局指标

主要结局

Eradication of gut colonizing bacteria as proven by at least two negative stool cultures.

时间窗: 2 weeks to 6 months after fecal microbiota transplantation

次要结局

  • Eradication of gut colonizing bacteria as proven by PCR.(2 weeks to 6 months after fecal microbiota transplantation)
  • Incidence of infective episodes(from day "0" (day of FMT) to 6 months after fecal microbiota transplantation)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Grzegorz W. Basak

Associate Professor

Medical University of Warsaw

研究点 (1)

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