Fecal Microbiota Transplant by Oral Capsules Enriched With Lactobacilli for Recurrent Clostridium Difficile Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 21
- 主要终点
- decrease in the number of evacuations
研究概览
简要总结
Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection
详细描述
Investigators designed an open, two-arm study to compare to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection.
From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal samples 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 FMT-c (15 capsules every 12 h by 2 days) or a FMT-c and Lactobacillus (15 capsules every 12 h by 2 days)
入排标准
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years With recurrent CDI
排除标准
- •Older than 18 years
研究组 & 干预措施
FMT-c
Patients in this arm received FMT-c (15 capsules every 12 h for 2 days)
干预措施: FMT-c (Biological)
FMT-c lactobacillus
Patients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days)
干预措施: FMT-c Lactobacillus (Biological)
结局指标
主要结局
decrease in the number of evacuations
时间窗: up to two days
The cure of CDI was measured
次要结局
未报告次要终点
研究者
Adrián Camacho-Ortiz
Principal Investigator
Universidad Autonoma de Nuevo Leon