Fecal Microbiota Transplant Versus Vancomycin for Treatment of Initial Clostridium Difficile Infection
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
- 否
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
Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days
干预措施: Vancomycin (Drug)
FMT-FURM
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
Adrián Camacho-Ortiz
Dr.
Universidad Autonoma de Nuevo Leon
