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临床试验/NCT02857582
NCT02857582已完成2 期

Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

Per Hellström1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Secondary treatment for relapse of Clostridium difficile infection.

干预措施: Vancomycin (Drug)

Vancomycin

Active Comparator

Secondary treatment for relapse of Clostridium difficile infection.

干预措施: Metronidazole (Drug)

Cultured human intestinal microbiota1

Experimental

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

Experimental

Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.

干预措施: Metronidazole (Drug)

Cultured human intestinal microbiota2

Experimental

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

Experimental

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

发起方
Per Hellström
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Per Hellström

Professor

Uppsala University

研究点 (1)

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