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临床试验/NCT03107169
NCT03107169已完成不适用

Fecal Microbiota Transplant Versus Vancomycin for Treatment of Initial Clostridium Difficile Infection

Universidad Autonoma de Nuevo Leon0 个研究点目标入组 10 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
主要终点
Decrease in number of evacuations

研究概览

简要总结

Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.

详细描述

Investigators designed an open, two-arm study to compare oral vancomycin with an FMT-FURM as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients. From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Specimens are cultured to isolate C. difficile, and C. difficile are assessed for the presence of genes encoding enterotoxin (tcdB), cytotoxin (tcdA), the binary toxin A (cdtA), binary toxin B (cdtB), and deletions within the negative regulator of toxin A and B production (tcdC) by polymerase chain reaction (PCR). The minimum inhibitory concentrations (MICs) of ciprofloxacin, moxifloxacin, erythromycin, clindamycin, vancomycin, metronidazole, linezolid, fidaxomicin, and tetracycline against C. difficile are measured using the agar dilution method. Fecal samples and FMT-FURM are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients were randomized by a closed envelope method in a 1: 1 ratio to either oral vancomycin (every 6 h for 10-14 days) or a FMT-FURM

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

  • Clinical diagnosis of CDI (first episode)
  • Older than 18 years old

排除标准

  • Patients younger than 18 years old

研究组 & 干预措施

Vancomycin

Active Comparator

Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days

干预措施: Vancomycin (Drug)

FMT-FURM

Experimental

Patients in this arm receive FMT-FURM

干预措施: FMT (Other)

结局指标

主要结局

Decrease in number of evacuations

时间窗: up to a 2 days

The cure of CDI was measured

次要结局

未报告次要终点

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrián Camacho-Ortiz

Dr.

Universidad Autonoma de Nuevo Leon

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