Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Normalization of stool consistency
研究概览
简要总结
Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. In case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. As an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. In both cases As an alternative cultured gut microbiota may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of Clostridium difficile.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Antibiotic-induced diarrhea
- •Positive fecal analysis for Clostridium difficile toxin
排除标准
- •Antibiotic treatment
- •Probiotic treatment
- •Intestinal infection other than Clostridium difficile
- •Inflammatory bowel disease (Ulcerative colitis, Crohn's disease
- •Immunodeficiency (drug- och disease-related)
- •Pregnancy
- •Unable to accept endoscopic procedures
- •Unable to give informed consent
研究组 & 干预措施
Vancomycin
Secondary treatment for relapse of Clostridium difficile infection.
干预措施: Vancomycin (Drug)
Vancomycin
Secondary treatment for relapse of Clostridium difficile infection.
干预措施: Metronidazole (Drug)
Cultured human intestinal microbiota1
Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
干预措施: Cultured human intestinal microbiota (Biological)
Cultured human intestinal microbiota1
Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
干预措施: Metronidazole (Drug)
Cultured human intestinal microbiota2
Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
干预措施: Cultured human intestinal microbiota (Biological)
Cultured human intestinal microbiota2
Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
干预措施: Metronidazole (Drug)
结局指标
主要结局
Normalization of stool consistency
时间窗: 90 days
Normalization according to Bristol stool scale
次要结局
- Normalization of stool frequency(90 days)
研究者
Per Hellström
Professor
Uppsala University
